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System, Imaging, Optical Coherence Tomography (Oct)
FDA product code NQQ · Class 2 · Radiology
108
Registered devices
69
Adverse events
3
Recalls
46
510(k) clearances
Devices with this code
NvisionVLE Marking Console — NINEPOINT MEDICAL, INC.OPTIS™ — LIGHTLAB IMAGING, INC.NvisionVLE Imaging Console — NINEPOINT MEDICAL, INC.Pantheris SV — AVINGER, INC.Pantheris — Zylox-Tonbridge Medical Technology Co., Ltd.OPTIS™ — ST. JUDE MEDICAL, INC.AptiVue™ — LIGHTLAB IMAGING, INC.Pantheris — Zylox-Tonbridge Medical Technology Co., Ltd.Pantheris — AVINGER, INC.Novasight Hybrid™ Hummingbird Console — Conavi Medical IncOPTIS™ — LIGHTLAB IMAGING, INC.NvisionVLE Low Profile Imaging Probe, 0mm Working Distance — NINEPOINT MEDICAL, INC.NvisionVLE Marking Console with IRIS, Refurbished — NINEPOINT MEDICAL, INC.OPTIS™ — ST. JUDE MEDICAL, INC.OPTIS™ — LIGHTLAB IMAGING, INC.HyperVue Imaging System — Spectrawave, Inc.Ocelot III — AVINGER, INC.OPTIS™ — ST. JUDE MEDICAL, INC.Tigereye — AVINGER, INC.NvisionVLE Marking Probe 14mm — NINEPOINT MEDICAL, INC.NvisionVLE Marking Probe 20mm Clinical — NINEPOINT MEDICAL, INC.OPTIS™ — ST. JUDE MEDICAL, INC.Gentuity HF-OCT Imaging System — GENTUITY LLCOPTIS™ — LIGHTLAB IMAGING, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-11 | Ninepoint Medical Inc. | Distal tips of the probes may detach from the probe shaft during use. |
| 2011-12-22 | Imalux Corporation | During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit. |
| 2010-07-20 | Optovue Inc. | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. |
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