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OPHTHALMOSCOPE

NIDEK CO.,LTD. · Model F-10 · UDI-DI 04987669100561

MYC Prescription
10
510(k) clearances
4
Adverse events (2 deaths)
0
Recalls
14
Facilities

Description

The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.