Cleared Traditional

BriefCase

K213721 · Aidoc Medical , Ltd. · Radiology

Mar 2022

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K213721 is an FDA 510(k) clearance for the BriefCase, a Radiological Computer-assisted Triage And Notification Software (Class II — Special Controls, product code QAS), submitted by Aidoc Medical , Ltd. (Tell-Aviv, IL). The FDA issued a Cleared decision on March 21, 2022, 117 days after receiving the submission on November 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number	K213721 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2021
Decision Date	March 21, 2022
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QAS — Radiological Computer-assisted Triage And Notification Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2080
Definition	Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .