FDA 510(k), K193658, Viz ICH
FDA 510(k), K193658, Viz ICH
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510(K) Number: K193658
Device Name: Viz ICH
Manufacturer: Viz.ai, Inc.
Device Classification Name: radiological computer-assisted triage and notification software
Regulation Number: 892.2080
Classification Product Code: QAS
Date Received: 12/30/2019
Decision Date: 03/18/2020
Regulation Medical Specialty: Radiology
Device Name: Viz ICH
Manufacturer: Viz.ai, Inc.
Device Classification Name: radiological computer-assisted triage and notification software
Regulation Number: 892.2080
Classification Product Code: QAS
Date Received: 12/30/2019
Decision Date: 03/18/2020
Regulation Medical Specialty: Radiology
- 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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