Retcam 3 Ophthalmic Imaging System

510(k) K081858

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK081858	Date5 Nov 2008Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1265-2014 FDA Class II initiated 7 Mar 2014
One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.
- Terminated Z-1154-2014 FDA Class II initiated 24 Jan 2014
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
- Terminated Z-1099-2012 FDA Not yet classified initiated 2 Feb 2012
Still images extracted from video recordings may be mislabeled as to right and left eye.

1 jurisdiction

United States — FDA 510(k) Active

510(k)