Data / Medical devices / Israel / Aidoc Medical Ltd.

Aidoc Medical Ltd.: FDA-registered device maker in Tel Aviv-Yafo, Israel, 23 510(k) clearances

Name: Aidoc Medical Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Aidoc Medical Ltd. is registered with the FDA (registration 3014938447) in Tel Aviv-Yafo, Israel. It lists 5 device types. The FDA files 23 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Aidoc Medical Ltd.

FDA registration number: 3014938447
Address: 34, Ha-Masger, Tel Aviv-Yafo, Israel, 6721119
Owner or operator: Aidoc Medical Ltd. (10058842)
Roles: Manufacturer
First device listed: October 5, 2021
Registered through: 2027
Brand names listed: BriefCase, BriefCase-Quantification CAC, BriefCase-Quantification MLS, BriefCase-Quantification of Aortic Measurement (M-Aorta), BriefCase-Quantification of M-AbdAo, BriefCase-Triage, BriefCase-Triage Central PE, BriefCase-Triage for AD and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Prioritization Software For Lesions	QFM	2	Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 14, 2026	K261317	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
February 26, 2026	K253578	BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
January 27, 2026	K251195	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
January 7, 2026	K252970	BriefCase-Triage: CARE Multi-triage CT Body	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
November 6, 2025	K253265	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
May 30, 2025	K251406	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
February 14, 2025	K250248	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
November 22, 2024	K242203	BriefCase-Quantification	QIH	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
October 18, 2024	K242837	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
July 12, 2024	K241727	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
May 15, 2024	K241112	BriefCase-Quantification	QIH	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
November 28, 2023	K231631	BriefCase-Quantification	JAK	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
November 13, 2023	K232083	BriefCase-Quantification	QIH	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
October 30, 2023	K232751	BriefCase-Triage	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
February 1, 2023	K230020	BriefCase	QFM	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
December 5, 2022	K222692	BriefCase	QFM	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
November 18, 2022	K221330	BriefCase	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
October 7, 2022	K220709	BriefCase	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
September 28, 2022	K222329	BriefCase	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
June 3, 2022	K221314	BriefCase	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
May 17, 2022	K221240	BriefCase	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
March 14, 2022	K214043	BriefCase	QFM	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov
June 19, 2020	K193298	BriefCase	QAS	Substantially Equivalent	Aidoc Medical , Ltd.	accessdata.fda.gov

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Updated May 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.