Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...
Modality
CT/CTA
Anatomy
Spine; craniomaxillofacial; musculoskeletal anatomy; and patient-specific printed models
Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a...
UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative...
Modality
Radiological images; modality varies or is not specified in FDA list
Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.
Modality
X-ray/Radiography
Anatomy
Musculoskeletal and chest/ribs radiographs across specified views
Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth...
Modality
X-ray/Radiography
Anatomy
Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
Magnifico Open is a general-purpose MRI system that acquires, displays, and analyzes MR images and real-time imaging for the labeled body regions and open-MRI applications.
BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...
Modality
CT/CTA
Anatomy
Chest and abdomen; pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture/dislocation
SIGNA Bolt is a whole-body MRI system for high-resolution diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol...
SIGNA Sprint Select is a whole-body MRI system for diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol functions.
qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...
Modality
X-ray/Radiography
Anatomy
Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
Analyzes two-dimensional bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize caries, calculus, periapical radiolucency,...
AutoDensity estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment; it is not a replacement for...
Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including...
Modality
CT/CTA
Anatomy
Thoracic and lumbar spine, musculoskeletal, craniomaxillofacial, and vascular anatomy
Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole spine and other clinical image regions represented in supported CT and MR workflows
AIAS Cephalon assists qualified healthcare professionals during adult proximal femur fracture surgery by measuring and positioning implant components relative to bone structures...
uDR Aurora CX acquires two-dimensional X-ray images of the labeled skull, spine, chest, abdomen, extremities, limbs, and trunk for review by qualified healthcare professionals; it...
Modality
X-ray/Radiography
Anatomy
Skull, spine, chest, abdomen, extremities, limbs, and trunk
SIGNA Sprint is a 1.5T whole-body MRI system for diagnostic imaging of the labeled head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and...
Automatic MRI segmentation and quantitative analysis of muscle, bone, fat, and other anatomical structures to assist visualization and measurement; not direct disease diagnosis.
Modality
MRI
Anatomy
Muscles, bones, and adipose tissue across the lower extremities and upper body from neck to hips, plus other segmented structures
Opportunistically analyzes standard AP hip or pelvis radiographs in patients aged 50 years and older and issues a report when the estimated femoral-neck BMD is below a preset...
Definium Tempo Select acquires, displays, and manages digital radiographic images of the skull, spine, chest, abdomen, extremities, and other labeled body parts for routine...
Modality
X-ray/Radiography
Anatomy
Skull; spinal column; chest; abdomen; extremities; and other routine radiography anatomy
VEA Align is cloud-based software for orthopedic applications in adult and pediatric populations using two-dimensional X-ray images from EOS imaging systems to display interactive...
Modality
X-ray/Radiography
Anatomy
Spine and lower-limb alignment; frontal and lateral EOS images and associated 3D datasets
UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements,...
Modality
Radiological images; modality varies or is not specified in FDA list
Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...
Modality
Radiological images; modality varies or is not specified in FDA list
Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.
Accuro 3S is portable B-mode ultrasound with SpineNav-AI for lumbar-spine scouting and epidural-depth estimation during neuraxial-anesthesia and needle or catheter placement...
Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental...
uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...
Modality
CT/CTA
Anatomy
Colon, lungs and airway, vessels, brain, heart, liver, ribs, spine, and other CT regions
Second Opinion BLE identifies and displays bone-level measurements in bitewing and periapical radiographs for dental health professionals reviewing permanent teeth in patients age...
Analyzes existing CT images in DICOM format from adults aged 30 years and older to estimate average areal BMD of spinal bones and flag low bone density below a preset threshold,...
SIGNA Prime Elite is a whole-body MR system that produces cross-sectional, spectroscopic, parametric, and dynamic images of the labeled body regions for trained physician...
BoneMetrics is fully automated software that assists trained radiology professionals with Cobb-angle measurement on frontal spine radiographs in patients aged four years or older...
Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations,...
Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle,...
Clarify DL is a deep-learning reconstruction function intended to reduce noise and improve image quality of nuclear-medicine bone SPECT scintigraphy for all ages on the supported...
Ortho AI measures lengths, angles, and implant position relative to bone on radiographic images for total hip arthroplasty, total knee arthroplasty, and lumbar-spine fusion...
Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is...
Modality
MRI
Anatomy
Lumbar spine, including vertebral bodies L1-S1, intervertebral discs, cord canal, dural sac, nerve roots, and posterior arch.
Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.
RemedyLogic AI MRI Lumbar Spine Reader (“RAI”) is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired...
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, in adults or...
SIGNA MAGNUS is a head-only MR system intended for diagnostic imaging of structures and functions of the head, neck, temporomandibular joint, and limited cervical spine in...
Modality
MRI
Anatomy
Head, neck, temporomandibular joint, and limited cervical spine
Tracked B-mode ultrasound acquisition, display, and scoliosis-angle measurement of the spine for trained users as an adjunct to conventional imaging; it is not the sole basis for...
Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat...
Modality
MRI
Anatomy
Lower extremities; 72 muscles and 8 bones including pelvis, femur, tibia, and fibula, bilaterally
Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...
Modality
CT/CTA
Anatomy
Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
Omni Legend is a PET/CT system for attenuation-corrected PET with positron-emitting radiopharmaceuticals across whole-body, head, heart, brain, lung, breast, bone,...
Assists radiologists and emergency physicians in detecting fractures on DICOM musculoskeletal radiographs for adults and children aged 2 years or older, limited to the FDA-listed...
SubtleSYNTH is a software medical device consisting of a machine-learning algorithm that synthesizes a SynthSTIR contrast image from T1-weighted and T2-weighted spine MR images.
VEA Align uses 2D X-ray images acquired in EOS imaging systems to display interactive landmarks and support global-alignment assessment, angle and length measurements, and...
Modality
X-ray/Radiography
Anatomy
Spine and lower limbs; global alignment and deformity
O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact...
Aid pediatric radiologists in assessing bone age from PA left-hand radiographs for patients aged 2-16 years; the result is an adjunct and must not be used alone for diagnostic...
Parallel worklist triage for suspected vertebral compression fractures in patients aged 50 years and over within the standard-of-care bone-health setting; not a diagnostic device
Modality
CT/CTA
Anatomy
Thoracic and lumbar vertebrae T1-L5 within chest and/or abdomen CT
YSIO X.pree is a digital X-ray system designed to visualize anatomical structures and generate X-ray images from the whole body, including the skull, chest, abdomen, spine, limbs,...
Modality
X-ray/Radiography
Anatomy
Skull, chest, abdomen, spine, extremities, limbs, and trunk
uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...
Modality
CT/CTA
Anatomy
Colon, jaw, lungs, airways, brain, heart, vessels, liver, spine, ribs, and other labeled CT regions
Rho analyzes standard frontal radiographs opportunistically to identify patients aged 50 years and older who may have low bone mineral density and to prompt clinical bone-health...
Modality
X-ray/Radiography
Anatomy
Lumbar spine, thoracic spine, chest, pelvis, knee, hand, and wrist; low bone-mineral-density screening regions
MRI-based BoneMRI image enhancement for visualizing pelvic and cervical, thoracic, lumbar and S1 spinal bone structures with CT-like radiodensity contrast; not for tumor diagnosis...
The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra,...
Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body
VEA Align is cloud-based orthopedic software that uses 2D frontal and lateral X-ray images acquired in EOS imaging systems to display interactive landmarks and support...
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...
Adravision Perio is semi-automated radiological image-processing software intended to aid dental professionals in measuring mesial and distal bone levels associated with each...
aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it...
Modality
Radiological images; modality varies or is not specified in FDA list
Second-reader CADe support for detecting/highlighting caries and periapical radiolucency and for measuring mesial and distal bone levels on extraoral and intraoral 2D dental...
The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including...
Use with CT images to automatically generate anatomically focused multi-planar spine reformats, apply vertebral-body and intervertebral-disc labels, and export the results to...
The ECHELON Synergy MRI system is a 1.5T MR imaging device that provides non-ionizing physiological and clinical information and produces transverse, coronal, sagittal, oblique,...
Modality
MRI
Anatomy
Head, spine, cardiac, breast, abdomen, pelvis, shoulder, wrist, knee, ankle, and other labeled whole-body regions
Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration...
Modality
X-ray/Radiography
Anatomy
Spine, including sagittal lumbar and cervical spine; femoral-head landmarks for spinopelvic measurements
DeepCatch analyzes whole-body CT images to segment skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and central nervous system structures, then calculates...
MRI image enhancement by reducing image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increasing image sharpness for head MRI.
Modality
MRI
Anatomy
Head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions
DTX Studio Clinic 3.0 analyzes intraoral bitewing and periapical radiographs of permanent teeth in patients aged 15 years and older to identify and localize caries, calculus,...
RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine, including cervical and lumbar vertebrae; general DICOM images excluding mammography
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
Spectral Bone Marrow is an automated image processing software application, utilizing deep learning technology for bone segmentation, to facilitate optimized visualization of bone...
BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs,...
The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, lung, brain, liver, cardiac, coronary, and other anatomy represented in labeled nuclear-medicine studies
MRI-based BoneMRI v1.6 image enhancement for visualizing pelvic and L3-S1 lumbar bone structures with enhanced contrast; not for tumor diagnosis or monitoring and not a CT...
SIGNA Victor is a whole-body magnetic-resonance scanner for high-resolution imaging, high signal-to-noise ratio, and short scan times. It is indicated to produce axial, sagittal,...
Modality
MRI
Anatomy
Entire body including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions
Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and...
Chest CT (with or without contrast) triage and notification for suspected three or more acute rib fractures in adults or transitional adolescents age 18 or older; notifications...
Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and...
BoneMRI enhances bone contrast in dedicated MRI examinations of the pelvic sacrum, hip bones, femoral heads, and lumbar spine from L3 through S1; it is not intended to diagnose or...
Modality
MRI
Anatomy
Pelvic sacrum, hip bones, femoral heads, and lumbar spine L3-S1
AI-Rad Companion (Musculoskeletal) is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to...
Spine CMAP is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP can be used to obtain...
The Automated Bone Mineral Density Software Module measures bone mineral density from existing CT by averaging Hounsfield units in trabecular vertebral bone and can calculate age-...
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR)...
Computer-assisted detection and diagnosis to assist radiologists and emergency physicians in detecting fractures on specified adult musculoskeletal radiographs; indicated for...
Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss...
Modality
CT/CTA
Anatomy
Spine, including T1-L4 vertebrae and T11-L4 trabecular bone regions
BoneView is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.
The UNiDTM Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons...
BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and...
Aquilion Exceed LB is a CT system for cross-sectional imaging of the labeled body regions and examinations described in K211828, with professional review of acquired and...
Modality
CT/CTA
Anatomy
Head, neck, chest, abdomen, pelvis, spine, extremities, and other CT anatomy
Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels...
Parallel triage and notification of suspect cases with three or more acute rib-fracture pathologies to assist hospital-network workflow prioritization; not a diagnostic device.
SubtleMR is MRI image-processing software for reducing noise in supported head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI or increasing sharpness for...
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks...
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...
Modality
CT/CTA
Anatomy
Adult head, brain, cervical spine, pulmonary arteries, and thorax
The Zebra HealthJOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative...
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the...
qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital...
Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral...
Modality
CT/CTA
Anatomy
Vertebral bodies and spine as seen on chest and abdominal CT; suspected vertebral compression fractures
Software provides quantitative and qualitative analysis of previously acquired CT DICOM images to support radiologists and physicians in the evaluation and assessment of...
PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning...
aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine on CT images. The device is intended to assist...
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by...
Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.