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510(k) K253101

HyperVue™ Imaging System - Integrated by Spectrawave, Inc. — Product Code NQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2025
Date Received
September 24, 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 by Spectrawave, Inc.

  • K251355 — X1-FFR (October 17, 2025)
  • K251198 — HyperVue™ Software (July 16, 2025)
  • K243016 — Starlight Imaging Catheter (March 20, 2025)
  • K230691 — HyperVue™ Imaging System (June 7, 2023)
  • K221257 — SpectraWAVE Imaging System (February 28, 2023)

Other clearances for product code NQQ

  • K251730 — LIA Console (542-7) (December 19, 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)
  • K240610 — deepLive (July 9, 2024)
  • K232386 — ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with Apt (September 8, 2023)