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510(k) K153479

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System by Ninepoint Medical, Inc. — Product Code NQQ

Clearance Details

Decision
SESU ()
Decision Date
February 16, 2016
Date Received
December 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Optical Coherence Tomography (Oct)
Device Class
Class II
Regulation Number
892.1560
Review Panel
SU
Submission Type

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

Other clearances by Ninepoint Medical, Inc.

  • K191117 — NvisionVLE Low-profile Optical Probe (July 19, 2019)
  • K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (November 2, 2018)
  • K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe (October 16, 2018)
  • K143678 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Access (February 6, 2015)
  • K120800 — NVISION VLE IMAGING SYSTEM (April 25, 2013)
  • K121195 — NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER (July 25, 2012)
  • K112770 — NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER (December 16, 2011)

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