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Gentuity HF-OCT Imaging System
GENTUITY LLC · Model SW 23.3.13 · UDI-DI 00859910007032
NQQ
Prescription
1
510(k) clearances
69
Adverse events
3
Recalls
27
Facilities
Description
Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.
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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