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Camera, Ophthalmic, Ac-Powered
FDA product code HKI · Class 2 · Ophthalmic
212
Registered devices
150
Adverse events
9
Recalls
157
510(k) clearances
Devices with this code
JEDMED — JEDMED INSTRUMENT COMPANYS4 OPTIK — COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRLiFusion — OPTOVUE, INC.JEDMED — JEDMED INSTRUMENT COMPANYiFusion — OPTOVUE, INC.3nethra — FORUS HEALTH PRIVATE LIMITEDKOWA nonmyd 8 — KOWA COMPANY,LTD.iFusion — OPTOVUE, INC.Neolight — NEOLIGHT LLCPictor Prestige - Full Kit (VPPHAND, VPPRET and VPPANT) — VOLK OPTICAL INC.Volk Pictor VP1Handset, VP1RET and VP1ANT — VOLK OPTICAL INC.Neolight — NEOLIGHT LLCJEDMED — JEDMED INSTRUMENT COMPANYOptomed Smartscope FA — Optomed OyOptomed Aurora full set — Optomed OyRETINAL CAMERA TRC-50DX — TOPCON CORPORATIONNatus — XLTEKJEDMED — JEDMED INSTRUMENT COMPANYESSILOR RETINA 800 — ESSILOR INTERNATIONALKOWA VX-20 — KOWA COMPANY,LTD.Mydriatic Hyperspectral Retinal Camera — Optina Diagnostiques, Inc3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton — TOPCON CORPORATIONRetinaStation — CRYSTALVUE MEDICAL CORPORATIONKOWA nonmyd 7 — KOWA COMPANY,LTD.
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. |
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