FDA 510(k) K153479, NvisionVLE Imaging Console, Marking Probes (14/17/20mm) and Inflation System, by Ninepoint Medical, Inc.
FDA 510(k) K153479, NvisionVLE Imaging Console, Marking Probes (14/17/20mm) and Inflation System, by Ninepoint Medical, Inc.
Device Name: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
Manufacturer: Ninepoint Medical, Inc.
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 12/02/2015
Decision Date: 02/16/2016
Regulation Medical Specialty: Radiology
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