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510(k) K192922

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter by Gentuity, LLC — Product Code NQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2020
Date Received
October 16, 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 Gentuity, LLC

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  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)

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  • 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)
  • K240610 — deepLive (July 9, 2024)