Product code NQQ— Radiology
ILUMIEN OPTIS
- Advisory panel
- Radiology
- Total cleared
- 46
Recent clearances under product code NQQ
- K253459 — OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- K251730 — LIA Console (542-7)
- K253101 — HyperVue Imaging System - Integrated
- K252851 — deepLive (OSP12 + DMS)
- K251198 — HyperVue Software
- K250684 — OPUSWAVE Dual Sensor Imaging System
- K242924 — OPXION Optical Skin Viewer (OPXSV1-01F)
- K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
- K243016 — Starlight Imaging Catheter
- K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
- K240610 — deepLive
- K232386 — ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
- K230691 — HyperVue Imaging System
- K221257 — SpectraWAVE Imaging System
- K210458 — OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
- K203578 — OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
- K201552 — ApolloVue S100 Image System
- K192922 — Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
- K191117 — NvisionVLE Low-profile Optical Probe
- K183320 — Ilumien Optis, Optis Integrated, Optis Mobile
- K190404 — OTIS Optical Coherence Tomography SYstem
- K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K171560 — OTIS Optical Coherence Tomography System
- K162466 — LuminScan (TM) Imaging System
- K153283 — VivoSight Dx Topical OCT System
- K160878 — OPTIS Metallic Stent Optimization E.4 SW
- K160240 — Perimeter Otis 1.0 Optical Coherence Tomography System
- K153479 — NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
- K152120 — OPTIS Mobile System
- K151286 — OPTIS Integrated System Mobile Workstation
- K150878 — ILUMIEN OPTIS
- K150237 — ILUMIEN, Drageonfly OPTIS Imaging Catheter
- K143678 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
- K133209 — FORESEE (4C) IMAGING SYSTEM
- K132800 — SKINTELL
- K120800 — NVISION VLE IMAGING SYSTEM
- K123369 — ILUMIEN OPTIS
- K121195 — NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
- K112770 — NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
- K111201 — C7 XR IMAGING SYSTEM
- K102599 — TOMOPHASE OCTIS
- K093857 — C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
- K093520 — VIVOSIGHT TOPICAL OCT SYSTEM
- K042894 — IMALUX NIRIS IMAGING SYSTEM
- K033783 — IMALUX OCT IMAGING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.