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FDA 510(k), K180647, BriefCase
FDA 510(k), K180647, BriefCase
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510(K) Number: K180647
Device Name: BriefCase
Manufacturer: Aidoc Medical, Ltd.
Device Classification Name: radiological computer-assisted triage and notification software
Regulation Number: 892.2080
Classification Product Code: QAS
Date Received: 03/12/2018
Decision Date: 08/01/2018
Regulation Medical Specialty: Radiology
Device Name: BriefCase
Manufacturer: Aidoc Medical, Ltd.
Device Classification Name: radiological computer-assisted triage and notification software
Regulation Number: 892.2080
Classification Product Code: QAS
Date Received: 03/12/2018
Decision Date: 08/01/2018
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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