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FDA 510(k), K171435, VirtuOst Vertebral Fracture Assessment
FDA 510(k), K171435, VirtuOst Vertebral Fracture Assessment
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510(K) Number: K171435
Device Name: VirtuOst Vertebral Fracture Assessment
Manufacturer: David Kopperdahl
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 05/15/2017
Decision Date: 08/03/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: VirtuOst Vertebral Fracture Assessment
Manufacturer: David Kopperdahl
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 05/15/2017
Decision Date: 08/03/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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