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510(k) K121195

NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER by Ninepoint Medical, Inc. — Product Code NQQ

K121195 is an FDA 510(k) premarket notification submitted by Ninepoint Medical, Inc. for the device "NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER". The FDA issued a decision of Substantially Equivalent on July 25, 2012. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. Ninepoint Medical, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
April 19, 2012
Clearance Type
Special
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)
  • 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)
  • K112770 — NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER (December 16, 2011)

Other clearances for product code NQQ

  • K253459 — OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (April 24, 2026)
  • K251730 — LIA Console (542-7) (December 19, 2025)
  • K253101 — HyperVue™ Imaging System - Integrated (December 15, 2025)
  • K252851 — deepLive (OSP12 + DMS) (October 7, 2025)
  • K251198 — HyperVue™ Software (July 16, 2025)
  • K250684 — OPUSWAVE Dual Sensor Imaging System (July 2, 2025)
  • K242924 — OPXION Optical Skin Viewer (OPXSV1-01F) (June 23, 2025)
  • K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging Sy (April 11, 2025)
  • K243016 — Starlight Imaging Catheter (March 20, 2025)
  • K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), (August 16, 2024)

FDA data resources