Medical Device Manufacturer · IL , Tel Aviv

Aidoc Medical , Ltd. - FDA 510(k) Cleared Devices

34 submissions · 34 cleared · Since 2018

Total

Cleared

Denied

Aidoc Medical, Ltd. is a healthcare AI company based in Tel Aviv, Israel. The company develops clinical AI solutions for medical imaging and diagnostic workflows.

Aidoc has received 34 FDA 510(k) clearances from 34 total submissions since 2018. The company specializes exclusively in Radiology devices, with a dominant portfolio of FDA-cleared algorithms. The latest clearance was in 2026, confirming active regulatory engagement.

The company's product portfolio includes the BriefCase platform, featuring triage and quantification algorithms for CT imaging. Notable cleared devices address pneumothorax detection, multi-triage body imaging, and radiological quantification. Aidoc operates a proprietary enterprise platform designed for seamless integration into hospital IT infrastructure and care coordination workflows.

Explore the complete list of device names, product codes, and clearance dates in the database below.

Regulatory submissions have been managed by Hogan Lovells US LLP, Aidoc Medical , Ltd. and Hogan & Lovells U.S. Lpp. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Aidoc Medical , Ltd.

34 devices

1-12 of 34