Panels › Ophthalmic › Product code HKI · Class 2
Camera, Ophthalmic, Ac-Powered
Regulation 886.1120
3510(k)s in 12 months (157 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in HKI
| Company | 510(k)s | Recalls |
|---|---|---|
| Canon USA, Inc. | 19 | 0 |
| Kowa Co. , Ltd. | 14 | 0 |
| Clarity Medical Systems | 4 | 3 |
| Nidek Co., Ltd. | 5 | 2 |
| Topcon Corp. | 7 | 0 |
| Optomed OY | 5 | 0 |
| Nidek Technologies Srl | 4 | 0 |
| Tearscience, Inc. | 4 | 0 |
| Kowa Optimed, Inc. | 3 | 0 |
| Medivision Medical Imaging, Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2026 | K253176 | TearView Beyond 700 Pty, Ltd., AU | HKI |
| Jan 16, 2026 | K251353 | Eyer 2 Phelcom Technologies, BR | HKI |
| Dec 12, 2025 | K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) Remidio Innovative Solutions Private Limited, IN | HKI |
| Sep 4, 2025 | K250770 | Optina-4C (MHRC-C1N) Optina Diagnostics, Inc., CA | HKI |
| Aug 14, 2025 | K243600 | 3nethra neo HD FA; 3nethra neo HD Forus Health Pvt.Ltd, IN | HKI |
| Apr 30, 2025 | K250683 | Resolve Fundus Camera Optain Health, Inc. | HKI |
| Dec 17, 2024 | K243664 | Sentinel Camera Ai Optics | HKI |
| Dec 9, 2024 | K242508 | Verily Numetric Retinal Camera Verily Life Sciences, LLC | HKI |
| May 15, 2024 | K241049 | CANON Fundus Camera CR-10 (CR-10) Canon, Inc., JP | HKI |
| Dec 5, 2023 | K231230 | Optina-4C (MHRC-C1N) Optina Diagnostics, Inc., CA | HKI |
| Nov 20, 2023 | K230627 | Zilia Ocular FC (ZIL-10002) Zilia, Inc., CA | HKI |
| Sep 6, 2023 | K223575 | Phoenix ICON, Phoenix ICON GO Neolight, LLC | HKI |
| Mar 15, 2023 | K223381 | iExaminer System with Panoptic Plus Welch Allyn, Inc. | HKI |
| Feb 22, 2023 | K221329 | Eyer Retinal Camera NM-STD Phelcom Technologies, BR | HKI |
| Aug 29, 2022 | K221111 | Non-Mydriatic Retinal Camera NW500 Topcon Corporation, JP | HKI |
| Apr 13, 2021 | K210197 | NFC-600 Automated Portable Retinal Camera Crystalvue Medical Corporation, TW | HKI |
| Apr 13, 2021 | K203500 | RetCam Envision Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), CA | HKI |
| Feb 2, 2021 | K202097 | Fundus Camera Huvitz Co., Ltd., KR | HKI |
| Jan 29, 2021 | K202221 | VX650 Luneau Technology Operations, FR | HKI |
| Nov 20, 2020 | K201325 | Optomed Smartscope M5 with Optomed Smartscope FA Optomed Oyj, FI | HKI |
| Jul 23, 2020 | K201122 | Canon non-mydriatic retinal camera CR series Canon, Inc., JP | HKI |
| Jun 1, 2020 | K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System Vasoptic Medical, Inc. | HKI |
| Apr 27, 2020 | K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) Optina Diagnostics, CA | HKI |
| Jan 22, 2020 | K190954 | Fundus Camera Chongqing Bio Newvision Medical Equipment , Ltd., CN | HKI |
| Sep 10, 2019 | K191945 | KOWA nonmyd 8 Kowa Company , Ltd., JP | HKI |
| Jun 4, 2019 | K190573 | KOWA DR-1a Kowa Company , Ltd., JP | HKI |
| Apr 1, 2019 | K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S Nidek Co., Ltd., JP | HKI |
| Jan 2, 2019 | K182199 | NFC-700 non-mydriatic auto fundus camera Crystalvue Medical Corporation, TW | HKI |
| Dec 21, 2018 | K183059 | 3nethra neo Forus Health Pvt.Ltd, IN | HKI |
| Dec 10, 2018 | K182506 | LipiScan Dynamic Meibomian Imager Tearscience, Inc. | HKI |
| Sep 7, 2018 | K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable Natus Medical Incorporated | HKI |
| Jul 27, 2018 | K173474 | RetiCapture Ilooda Co,., Ltd., KR | HKI |
| Jun 8, 2018 | K180306 | Nexy Next Sight Srl, IT | HKI |
| Apr 5, 2018 | K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Optomed OY, FI | HKI |
| Sep 15, 2017 | K170527 | Phoenix Clinical ICON Phoenix Technology Group, Inc. Dba Phoenix Clinical | HKI |
| Apr 11, 2017 | K163021 | HAAG-STREIT FUNDUS MODULE 300 Optomed OY, FI | HKI |
| Oct 4, 2016 | K161727 | Eyenez Ophthalmic Camera Eyenez, LLC | HKI |
| Jun 6, 2016 | K152729 | MICROPERIMETER MP-3 Nidek Co., Ltd., JP | HKI |
| May 12, 2016 | K153239 | LSFG-NAVI Softcare Co., Ltd., JP | HKI |
| Jan 14, 2016 | K152869 | LipiView II Ocular Surface Interferometer Tearscience, Inc. | HKI |
| Oct 23, 2014 | K141325 | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA Topcon Corp. | HKI |
| Sep 17, 2014 | K141481 | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA Topcon Corporation | HKI |
| Jul 3, 2014 | K132987 | COBRA FUNDUS CAMERA C.S.O. S.R.L. | HKI |
| Jun 17, 2014 | K140450 | KEELER KAPTURE SOFTWARE Keeler Limited | HKI |
| Dec 18, 2013 | K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 Optomed OY, FI | HKI |
| Jul 3, 2013 | K130656 | IFUSION Optovue, Inc. | HKI |
| Jun 5, 2013 | K123101 | TRC-50DX RETINAL CAMERA Topcon Medical Systems, Inc. | HKI |
| May 10, 2013 | K130289 | TRC-NW8 NON-MYDRIATIC RETINAL CAMERA Topcon Corp. | HKI |
| Mar 19, 2013 | K123208 | DIGITAL RETINAL CAMERA Canon Inc. -Medical Equipment Group, JP | HKI |
| Feb 6, 2013 | K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA Topcon Medical Systems, Inc. | HKI |
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