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510(k) K250684

OPUSWAVE Dual Sensor Imaging System by Terumo Cardiovascular Systems Thi Plant — Product Code NQQ

K250684 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Thi Plant for the device "OPUSWAVE Dual Sensor Imaging System". The FDA issued a decision of Substantially Equivalent on July 2, 2025. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2025
Date Received
March 6, 2025
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 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)
  • 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)

FDA data resources