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FDA 510(k), K190362, HealthPNX
FDA 510(k), K190362, HealthPNX
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510(K) Number: K190362
Device Name: HealthPNX
Manufacturer: Zebra Medical Vision Ltd.
Device Classification Name: radiological computer-assisted prioritization software for lesions
Regulation Number: 892.2080
Classification Product Code: QFM
Date Received: 02/15/2019
Decision Date: 05/06/2019
Regulation Medical Specialty: Radiology
Device Name: HealthPNX
Manufacturer: Zebra Medical Vision Ltd.
Device Classification Name: radiological computer-assisted prioritization software for lesions
Regulation Number: 892.2080
Classification Product Code: QFM
Date Received: 02/15/2019
Decision Date: 05/06/2019
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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