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FDA 510(k), K161459, Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
FDA 510(k), K161459, Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
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510(K) Number: K161459
Device Name: Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Manufacturer: VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED
Device Classification Name: solid state x-ray imager (flat panel/digital imager)
Regulation Number: 892.1680
Classification Product Code: MQB
Date Received: 05/26/2016
Decision Date: 09/06/2016
Regulation Medical Specialty: Radiology
Device Name: Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Manufacturer: VARIAN MEDICAL SYSTEMS, X-RAY PRODUCTS-INFIMED
Device Classification Name: solid state x-ray imager (flat panel/digital imager)
Regulation Number: 892.1680
Classification Product Code: MQB
Date Received: 05/26/2016
Decision Date: 09/06/2016
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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