FDA-cleared K253682

DeepHealth ProstateAI

Quantib B.V.

Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.

Modality
MRI
Anatomy
Prostate and lesions within or extending from the prostate
Decision
2026-04-29
FDA-cleared K253780

SIGNA™ Bolt

Ge Medical Systems, LLC

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...

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and musculoskeletal anatomy
Decision
2026-02-06
FDA-cleared K253779

SIGNA™ Sprint Select

Ge Medical Systems, LLC

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.

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and musculoskeletal anatomy
Decision
2026-02-05
FDA-cleared K253091

ART-Plan+ (v3.1.0)

Therapanacea Sas

ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091....

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-12-23
FDA-cleared K251399

SIGNA™ Sprint

GE Medical Systems, LLC

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...

Modality
MRI
Anatomy
Head; neck; temporomandibular joint; spine; breast; heart; abdomen; pelvis; joints; prostate; vessels; and musculoskeletal anatomy
Decision
2025-09-11
FDA-cleared K250064

Dose+ (1.0)

Mvision AI Oy

Dose+ 1.0 uses locked machine-learning models to predict a patient-specific three-dimensional dose distribution for men receiving external-beam radiotherapy for localized prostate...

Modality
Radiotherapy Planning Imaging
Anatomy
Prostate/Pelvis
Decision
2025-09-04
FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

QP-Prostate CAD detects and marks suspected prostate lesions for clinically significant prostate cancer on bi-parametric T2-weighted and diffusion-weighted prostate MRI, returning...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-18
FDA-cleared K250379

SIGNA Prime Elite

GE Medical Systems, LLC

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...

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and musculoskeletal anatomy
Decision
2025-03-17
FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior...

Modality
MRI
Anatomy
Prostate
Decision
2025-03-05
FDA-cleared K242822

ART-Plan+ (v.3.0.0)

Therapanacea SAS

ART-Plan+ v3.0.0 assists trained radiation therapy professionals with reviewed CT and MR contour generation and automatic prostate treatment-plan generation for import into a...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-02-25
FDA-cleared K250035

Contour ProtégéAI+

MIM Software Inc.

Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive;...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomical regions; prostate, seminal vesicles, and urethra on T2 MR
Decision
2025-02-03
FDA-cleared K233196

Medihub Prostate

JLK Inc.

Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related...

Modality
MRI
Anatomy
Prostate
Decision
2024-06-21
FDA-cleared K233728

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

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
Decision
2024-01-19
FDA-cleared K233568

Ceevra Reveal 3+

Ceevra, Inc.

Process, review, analyze, communicate, and exchange multidimensional CT or MR images, including preliminary segmentation of normal anatomy, for preoperative surgical planning and...

Modality
CT/CTA; MRI
Anatomy
Multi-region normal anatomy represented in CT or MR images; validated examples include prostate, bladder, neurovascular bundles, kidney, artery, and vein
Decision
2023-12-05
FDA-cleared K231765

Contour ProtégéAI

MIM Software Inc.

Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, creates machine-learning contours for quantitative analysis, adaptive...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
Decision
2023-11-08
FDA-cleared K223623

SubtleMR (2.3.x)

Subtle Medical Inc.

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
Decision
2023-05-11
FDA-cleared K230772

Quantib Prostate

Quantib BV

Support trained medical professionals in processing, visualizing, editing, and interpreting prostate MR studies, including structured PI-RADS scoring; diagnosis must not be made...

Modality
MRI
Anatomy
Prostate, prostatic sub-regions, and user-selected potential lesions.
Decision
2023-04-17
FDA-cleared K223774

Contour ProtégéAI

MIM Software Inc.

Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, machine-learning contour creation for quantitative analysis, adaptive...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
Decision
2023-04-06
FDA-cleared K221680

Xeleris V Processing and Review System

GE Healthcare

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
Decision
2023-03-01
FDA-cleared K223439

SIGNA Victor

GE Healthcare (Tianjin) Company Limited

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
Decision
2023-02-13
FDA-cleared K222803

Oncospace

Oncospace, Inc.

Oncospace supports trained radiation therapy professionals with protocol configuration, machine-learning achievable-dose prediction, planning-objective exchange, and plan review...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-02-02
FDA-cleared K212783

ProstatID

ScanMed, LLC

Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or...

Modality
MRI
Anatomy
Prostate
Decision
2022-07-08
FDA-cleared K221106

Quantib Prostate

Quantib BV

Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume...

Modality
MRI
Anatomy
Prostate; prostate and prostatic sub-regions
Decision
2022-05-13
FDA-cleared K213976

Contour ProtégéAI

MIM Software Inc.

Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
Decision
2022-02-03
FDA-cleared K211655

aPROMISE

EXINI Diagnostics AB

aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Prostate
Decision
2021-07-27
FDA-cleared K202284

Oncospace

Oncospace, Inc.

Oncospace supports trained radiation therapy professionals with protocol configuration, achievable-dose prediction, planning-objective exchange, and plan review for prostate,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-03-12
FDA-cleared K203182

SubtleMR

Subtle Medical, Inc.

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...

Modality
MRI
Anatomy
Multi-region
Decision
2021-02-26
FDA-cleared K203582

QUIBIM Precision Prostate (qp-Prostate)

QUIBIM S.L.

qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The...

Modality
MRI
Anatomy
Prostate
Decision
2021-02-04
FDA-cleared K193306

PROView

GE Medical Systems SCS

PROView is an aiding tool for the clinicians to review multi-parametric prostate MR images following PI-RADS guidelines. It displays acquired and reformatted data for...

Modality
MRI
Anatomy
Prostate
Decision
2020-11-17
FDA-cleared K202501

Quantib Prostate

Quantib BV

Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional...

Modality
MRI
Anatomy
Prostate
Decision
2020-10-11
FDA-cleared K193283

AI-Rad Companion Prostate MR

Siemens Medical Solutions USA Inc.

AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images.

Modality
MRI
Anatomy
Prostate
Decision
2020-07-30
FDA-cleared K193252

Contour ProtegeAI

MIM Software Inc.

Contour ProtegeAI is used by trained medical professionals as a tool for automated processing of CT and MR medical images. It creates contours with machine-learning algorithms for...

Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in CT anatomy; prostate, seminal vesicles, and urethra on T2-weighted MR
Decision
2020-07-02
FDA-cleared K191278

RSI-MRI+

MultiModal Imaging Services Corporation (dba HealthLytix)

RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+...

Modality
MRI
Anatomy
Prostate
Decision
2019-11-19
FDA-cleared K170250

SmartTarget

SmartTarget, Ltd.

SmartTarget is an accessory for image-guided interventional and diagnostic prostate procedures that enhances two-dimensional transrectal ultrasound, reconstructs three-dimensional...

Modality
Ultrasound
Anatomy
Prostate
Decision
2017-06-07