Home › Device types › HKI
Camera, Ophthalmic, Ac-Powered
FDA product code HKI · Class 2 · Ophthalmic
217
Registered devices
150
Adverse events
9
Recalls
157
510(k) clearances
Devices with this code
Vitazi View™ — CRYSTALVUE MEDICAL CORPORATIONCANON INC. — CANON INC.Carl Zeiss Meditec — LUNEAU TECHNOLOGY OPERATIONSIMAGEnet 6 — TOPCON HEALTHCARE SOLUTIONS, INC.Natus — XLTEKTV RELAY LENS ADAPTER TL-211 for RETINAL CAMERA TRC-50DX — TOPCON CORPORATIONiFusion — OPTOVUE, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.RETINAL CAMERA TRC-50DX — TOPCON CORPORATIONZEISS — LUNEAU TECHNOLOGY OPERATIONSHalo — CRYSTALVUE MEDICAL CORPORATIONKOWA VX-20 — KOWA COMPANY,LTD.RetCam Envision — Natus Medical Denmark ApSVISUCAM 524 — Carl Zeiss Meditec AGPolaris — CRYSTALVUE MEDICAL CORPORATIONRETINAL CAMERA TRC-50DX — TOPCON CORPORATIONDiffuser — Phoenix Clinical3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2) — TOPCON CORPORATIONNeolight — NEOLIGHT LLCPhoenix ICON with Training Kit — Phoenix ClinicalFA Module — Phoenix ClinicalPictor M5WEY4 Volk FN — Optomed OyVolk Pictor Prestige full set — Optomed OySignal set — Optomed Oy
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-20 | Merge Healthcare, Inc. | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was |
| 2017-07-27 | Optovue, Inc. | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| 2016-12-09 | Merge Healthcare, Inc. | This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. |
| 2016-12-09 | Merge Healthcare, Inc. | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling produ |
| 2014-06-16 | Nidek Inc | Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image. |
| 2014-03-07 | Clarity Medical Systems Inc | 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 co |
| 2014-01-24 | Clarity Medical Systems Inc | 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 |
| 2013-08-01 | Nidek Inc | Under certain circumstances, the Left eye image may be saved as the Right eye image. |
| 2012-02-02 | Clarity Medical Systems Inc | Still images extracted from video recordings may be mislabeled as to right and left eye. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.