Home / 510(k) Clearances / K183320

510(k) K183320

Ilumien Optis, Optis Integrated, Optis Mobile by St. Jude Medical (Now Abbott Medical) — Product Code NQQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2019
Date Received
November 30, 2018
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 St. Jude Medical (Now Abbott Medical)

  • K183099 — QUANTIEN Measurement System (February 28, 2019)

Other clearances for product code NQQ

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