FDA-cleared K261317

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2026-05-14
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.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2026-01-27
FDA-cleared K253265

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-11-06
FDA-cleared K251406

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-05-30
FDA-cleared K250248

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2025-02-14
FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-12-11
FDA-cleared K242203

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-11-22
FDA-cleared K242837

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-10-18
FDA-cleared K241727

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2024-07-12
FDA-cleared K241112

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2024-05-15
FDA-cleared K231631

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-28
FDA-cleared K232083

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-13
FDA-cleared K230534

BriefCase-Quantification

Aidoc Medical, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CT/CTA
Anatomy
N/A
Decision
2023-11-08
FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-10-30
FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2023-02-01
FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-12-05
FDA-cleared K221330

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2022-11-18
FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-10-07
FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-09-28
FDA-cleared K222277

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-08-26
FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-06-03
FDA-cleared K221240

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-05-17
FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-04-26
FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2022-03-21
FDA-cleared K214043

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2022-03-14
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.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2020-06-19
FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-12-20
FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
Decision
2019-05-31
FDA-cleared K190072

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality
CT/CTA
Anatomy
N/A
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