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FDA 510(k), K182373, PowerLook Tomo Detection V2 Software
FDA 510(k), K182373, PowerLook Tomo Detection V2 Software
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510(K) Number: K182373
Device Name: PowerLook Tomo Detection V2 Software
Manufacturer: iCAD Inc.
Device Classification Name: radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
Regulation Number: 892.2090
Classification Product Code: QDQ
Date Received: 08/31/2018
Decision Date: 12/06/2018
Regulation Medical Specialty: Radiology
Device Name: PowerLook Tomo Detection V2 Software
Manufacturer: iCAD Inc.
Device Classification Name: radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
Regulation Number: 892.2090
Classification Product Code: QDQ
Date Received: 08/31/2018
Decision Date: 12/06/2018
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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