BriefCase

Radiological Computer-assisted Triage And Notification Software

Aidoc Medical, Ltd.

The following data is part of a premarket notification filed by Aidoc Medical, Ltd. with the FDA for Briefcase.

Pre-market Notification Details

• Device ID: K190896
• 510k Number: K190896
• Device Name: BriefCase
• Classification: Radiological Computer-assisted Triage And Notification Software
• Applicant: Aidoc Medical, Ltd. 92 Yigal Alon St. Tel-aviv, IL 6789134
• Contact: Nimrod Epstein
• Correspondent: John J. Smith; Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
• Product Code: QAS
• CFR Regulation Number: 892.2080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-05
• Decision Date: 2019-05-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290018052211	K190896	000
07290018052259	K190896	000