Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NQQ — Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
267 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated | ABBOTT MEDICAL | 2026-04-24 | 199 | 0 |
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 2025-12-19 | 196 | 0 |
| K253101 | HyperVue™ Imaging System - Integrated | Spectrawave, Inc. | 2025-12-15 | 82 | 0 |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | 2025-10-07 | 29 | 0 |
| K251198 | HyperVue™ Software | Spectrawave, Inc. | 2025-07-16 | 90 | 0 |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 | 118 | 0 |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | 2025-06-23 | 272 | 0 |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intr | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-04-11 | 267 | 0 |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | 2025-03-20 | 174 | 0 |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G1 | Gentuity, LLC | 2024-08-16 | 17 | 0 |
| K240610 | deepLive | Damae Medical | 2024-07-09 | 126 | 0 |
| K232386 | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mob | ABBOTT MEDICAL | 2023-09-08 | 30 | 0 |
| K230691 | HyperVue™ Imaging System | Spectrawave, Inc. | 2023-06-07 | 86 | 0 |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023-02-28 | 302 | 0 |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imag | ABBOTT MEDICAL | 2021-06-08 | 112 | 0 |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical C | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 | 80 | 0 |
| K201552 | ApolloVue S100 Image System | Apollo Medical Optics, Ltd. | 2020-09-02 | 84 | 0 |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Cat | Gentuity, LLC | 2020-02-20 | 127 | 0 |
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | 2019-07-19 | 84 | 0 |
| K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | 2019-04-02 | 123 | 0 |
| K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | 2019-03-26 | 35 | 0 |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, Nvision | Ninepoint Medical, Inc. | 2018-11-02 | 42 | 0 |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018-10-16 | 56 | 0 |
| K171560 | OTIS Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2017-08-25 | 87 | 0 |
| K162466 | LuminScan (TM) Imaging System | Micro-Tech (Nanjing) Co., Ltd. | 2016-11-29 | 88 | 0 |
| K153283 | VivoSight Dx Topical OCT System | Michelson Diagnostics, Ltd. | 2016-08-11 | 273 | 0 |
| K160878 | OPTIS Metallic Stent Optimization E.4 SW | Lightlab Imaging, Inc. | 2016-06-29 | 91 | 0 |
| K160240 | Perimeter Otis™ 1.0 Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2016-05-13 | 102 | 0 |
| K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm b | Ninepoint Medical, Inc. | 2016-02-16 | 76 | 0 |
| K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015-10-29 | 91 | 0 |
| K151286 | OPTIS Integrated System Mobile Workstation | Lightlab Imaging, Inc. | 2015-08-05 | 83 | 0 |
| K150878 | ILUMIEN OPTIS | Lightlab Imaging, Inc. | 2015-07-15 | 105 | 0 |
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | Lightlab Imaging, Inc. | 2015-05-05 | 92 | 0 |
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, Nvision | Ninepoint Medical, Inc. | 2015-02-06 | 44 | 0 |
| K133209 | FORESEE (4C) IMAGING SYSTEM | Diagnostic Photonics, Inc. | 2014-03-17 | 151 | 0 |
| K132800 | SKINTELL | Agfa Healthcare N.V. | 2014-03-03 | 178 | 0 |
| K120800 | NVISION VLE IMAGING SYSTEM | Ninepoint Medical, Inc. | 2013-04-25 | 405 | 0 |
| K123369 | ILUMIEN OPTIS | Lightlab Imaging, Inc. | 2013-01-30 | 90 | 0 |
| K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER | Ninepoint Medical, Inc. | 2012-07-25 | 97 | 0 |
| K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER | Ninepoint Medical, Inc. | 2011-12-16 | 84 | 0 |
| K111201 | C7 XR IMAGING SYSTEM | Lightlab Imaging, Inc. | 2011-08-10 | 103 | 0 |
| K102599 | TOMOPHASE OCTIS | Tomophase Corporation | 2010-12-01 | 82 | 0 |
| K093857 | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND | Lightlab Imaging, Inc. | 2010-04-30 | 135 | 0 |
| K093520 | VIVOSIGHT TOPICAL OCT SYSTEM | Michelson Diagnostics, Ltd. | 2010-01-05 | 53 | 0 |
| K042894 | IMALUX NIRIS IMAGING SYSTEM | Imalux Corporation | 2004-11-19 | 30 | 1 |
| K033783 | IMALUX OCT IMAGING SYSTEM | Imalux Coporation | 2004-03-01 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda