FDA-cleared K261317
BriefCase-Triage
Aidoc Medical, Ltd.
Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.
- Modality
- CT/CTA
- Anatomy
- Head/Brain
- Decision
- 2026-05-14
Vendor
Aidoc Medical, Ltd.
35 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K253578
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
Aidoc Medical, Ltd.
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
- Decision
- 2026-02-26
FDA-cleared K251195
BriefCase-Triage
Aidoc Medical, Ltd.
Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2026-01-27
FDA-cleared K252970
BriefCase-Triage: CARE Multi-triage CT Body
Aidoc Medical, Ltd.
Adult contrast-enhanced and non-contrast CT triage for 11 chest, abdominal, and pelvic findings: diverticulitis, abdominal-pelvic abscess, appendicitis, intestinal...
- Modality
- CT/CTA
- Anatomy
- Chest, Abdomen, and Pelvis
- Decision
- 2026-01-07
FDA-cleared K253265
BriefCase-Triage
Aidoc Medical, Ltd.
Adult abdominal CT triage for suspected intra-abdominal free gas.
- Modality
- CT/CTA
- Anatomy
- Abdomen
- Decision
- 2025-11-06
FDA-cleared K251406
BriefCase-Triage
Aidoc Medical, Ltd.
Parallel triage notification of suspected aortic dissection on contrast CT chest/abdomen; compressed previews are not diagnostic.
- Modality
- CT/CTA
- Anatomy
- Chest and abdomen; suspected aortic dissection
- Decision
- 2025-05-30
FDA-cleared K250248
BriefCase-Triage
Aidoc Medical, Ltd.
Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
- Modality
- CT/CTA
- Anatomy
- Chest and lungs
- Decision
- 2025-02-14
FDA-cleared K243548
BriefCase-Triage
Aidoc Medical, Ltd.
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.
- Modality
- CT/CTA
- Anatomy
- Ribs
- Decision
- 2024-12-11
FDA-cleared K242203
BriefCase-Quantification
Aidoc Medical, Ltd.
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta...
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2024-11-22
FDA-cleared K242837
BriefCase-Triage
Aidoc Medical, Ltd.
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...
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2024-10-18
FDA-cleared K241727
BriefCase-Triage
Aidoc Medical, Ltd.
Briefcase-Triage is a radiological computer- aided triage and notification software indicated for use in the analysis of CTPA images, in adults or transitional adolescents aged 18...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-07-12
FDA-cleared K241112
BriefCase-Quantification
Aidoc Medical, Ltd.
Briefcase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal...
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2024-05-15
FDA-cleared K231631
BriefCase-Quantification
Aidoc Medical, Ltd.
Four-category coronary artery calcification (CAC) assessment of plaques on non-cardiac-gated, non-contrast CT images that include the heart; preview images are informational and...
- Modality
- CT/CTA
- Anatomy
- Heart and coronary arteries
- Decision
- 2023-11-28
FDA-cleared K232083
BriefCase-Quantification
Aidoc Medical, Ltd.
Automatic measurement of brain midline shift on non-contrast head CT in adults or transitional adolescents aged 18 years and older, including single-time-point measurement and...
- Modality
- CT/CTA
- Anatomy
- Brain, specifically midline shift
- Decision
- 2023-11-13
FDA-cleared K230534
BriefCase-Quantification
Aidoc Medical, Ltd.
Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in...
- Modality
- CT/CTA
- Anatomy
- Abdominal aorta
- Decision
- 2023-11-08
FDA-cleared K232751
BriefCase-Triage
Aidoc Medical, Ltd.
Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care...
- Modality
- CT/CTA
- Anatomy
- Chest and central pulmonary arteries
- Decision
- 2023-10-30
FDA-cleared K230020
BriefCase
Aidoc Medical, Ltd.
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...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2023-02-01
FDA-cleared K222692
BriefCase
Aidoc Medical, Ltd.
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...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2022-12-05
FDA-cleared K221330
BriefCase
Aidoc Medical, Ltd.
BriefCase analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-11-18
FDA-cleared K220709
BriefCase
Aidoc Medical, Ltd.
Notification-only triage of adult head CTA for suspected complete large-vessel and medium-vessel occlusions; compressed previews are informational and the full study remains...
- Modality
- CT/CTA
- Anatomy
- Brain/Cerebrovascular
- Decision
- 2022-10-07
FDA-cleared K222329
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the...
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2022-09-28
FDA-cleared K222277
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2022-08-26
FDA-cleared K221314
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and...
- Modality
- CT/CTA
- Anatomy
- Brain/Cerebrovascular
- Decision
- 2022-06-03
FDA-cleared K221240
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-05-17
FDA-cleared K213886
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2022-04-26
FDA-cleared K213721
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CT Angio (CTA) images. The device is intended to assist...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2022-03-21
FDA-cleared K214043
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of Chest X-Ray images in adults or transitional adolescents aged 18...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-03-14
FDA-cleared K202992
BriefCase, RIB Fractures Triage (RibFx)
Aidoc Medical, Ltd.
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.
- Modality
- CT/CTA
- Anatomy
- Ribs and chest.
- Decision
- 2021-04-14
FDA-cleared K203508
BriefCase
Aidoc Medical, Ltd.
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
- Decision
- 2020-12-29
FDA-cleared K201020
BriefCase
Aidoc Medical, Ltd.
BriefCase analyzes contrast-enhanced chest CT for suspected pulmonary embolism and notifies or prioritizes the study in the labeled hospital or cloud worklist workflow; the output...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2020-08-26
FDA-cleared K193298
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital...
- Modality
- CT/CTA
- Anatomy
- Abdomen
- Decision
- 2020-06-19
FDA-cleared K192383
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital...
- Modality
- CT/CTA
- Anatomy
- Brain/Cerebrovascular
- Decision
- 2019-12-20
FDA-cleared K190896
BriefCase
Aidoc Medical, Ltd.
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...
- Modality
- CT/CTA
- Anatomy
- Spine
- Decision
- 2019-05-31
FDA-cleared K190072
BriefCase
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced CT and CTPA images. The device is intended to assist...
- Modality
- CT/CTA
- Anatomy
- Brain; Chest/Lung
- Decision
- 2019-04-15
FDA-cleared K180647
BriefCase
Aidoc Medical, Ltd.
BriefCase provides computer-assisted triage and notification for suspected intracranial hemorrhage on noncontrast head CT and or large-vessel occlusion on head CTA in parallel...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2018-08-01