System, Imaging, Optical Coherence Tomography (oct)
Radiology · 21 CFR 892.1560
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Recent MDR events
69 adverse event reports on file
- G10-01 GENTUITY HF-OCT IMAGING SYSTEMJun 12, 2026MalfunctionGentuity, Llc3011578544-2026-00054
- G30-01 VIS-RX MICRO-IMAGING CATHETERJun 12, 2026MalfunctionGentuity, Llc3011578544-2026-00056
- GENTUITY HF-OCT IMAGING SYSTEMJun 1, 2026MalfunctionGentuity, Llc3011578544-2026-00040
- GENTUITY HF-OCT IMAGING SYSTEMMay 28, 2026MalfunctionGentuity, Llc3011578544-2026-00031
- GENTUITY HF-OCT IMAGING SYSTEMMay 27, 2026MalfunctionGentuity, Llc3011578544-2026-00027
- GENTUITY HF-OCT IMAGING SYSTEMMay 27, 2026MalfunctionGentuity, Llc3011578544-2026-00029
- G30-01 VIS-RX MICRO-IMAGING CATHETERMay 26, 2026MalfunctionGentuity, Llc3011578544-2026-00021
- G10-01 GENTUITY HF-OCT IMAGING SYSTEMMay 26, 2026MalfunctionGentuity, Llc3011578544-2026-00024
- G10-01 GENTUITY HF-OCT IMAGING SYSTEMMay 22, 2026MalfunctionGentuiy, Llc3011578544-2026-00019
- G10-01 GENTUITY HF-OCT IMAGING SYSTEMMay 22, 2026MalfunctionGentuity, Llc3011578544-2026-00020
Event type breakdown
Recalls
3 recall events for this product code
- Imalux CorporationTerminatedFeb 1, 2012
Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH
During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
Z-0934-2012 · View FDA record ↗ - Optovue Inc.TerminatedFeb 1, 2011
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA
Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
Z-1004-2011 · View FDA record ↗ - Ninepoint Medical Inc.TerminatedUnknown
NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(1
Distal tips of the probes may detach from the probe shaft during use.
Z-1781-2018 · View FDA record ↗
Registered firms
69 firms currently registered for this product code
Zylox-tonbridge Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Gentuity, Llc
Sudbury, MA, US
Isomedix Operations Inc.
Northborough, MA, US
Abbott Medical
Westford, MA, US
Abbott Vascular
Temecula, CA, US
Rbc Development Llc Dba Rbc Medical Innovations Dba Vantage Medtech
Lenexa, KS, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Conavi Medical Inc
Toronto Ontario, CA
Michelson Diagnostics Ltd
Maidstone Kent, GB
Isomedix Operations, Inc.
Temecula, CA, US
Perimeter Medical Imaging Ai, Inc.
Toronto Ontario, CA
Sterigenics Radiation Technologies Canada, Inc
PORT COQUITLAM British Columbia, CA
510(k) clearances
46 clearances for this product code
- ABBOTT MEDICALApr 24, 2026
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- Leadoptik, Inc.Dec 19, 2025
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- Spectrawave, Inc.Dec 15, 2025
K253101 · HyperVue Imaging System - Integrated
- Damae MedicalOct 7, 2025
K252851 · deepLive (OSP12 + DMS)
- Spectrawave, Inc.Jul 16, 2025
K251198 · HyperVue Software
- Terumo Cardiovascular Systems Thi PlantJul 2, 2025
K250684 · OPUSWAVE Dual Sensor Imaging System
- Opxion Technology, Inc.Jun 23, 2025
K242924 · OPXION Optical Skin Viewer (OPXSV1-01F)
- Shenzhen Vivolight Medical Device & Technology Co., Ltd.Apr 11, 2025
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