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510(k) K191117

NvisionVLE Low-profile Optical Probe by Ninepoint Medical, Inc. — Product Code NQQ

Clearance Details

Decision
SESU ()
Decision Date
July 19, 2019
Date Received
April 26, 2019
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.

  • K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (November 2, 2018)
  • K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe (October 16, 2018)
  • K153479 — NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE M (February 16, 2016)
  • 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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