510(k) K243664
- Device
- Sentinel Camera
- Applicant
- Ai Optics
- 510(k) number
- K243664
- Product code
- HKI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-17
- Date received
- 2024-11-27
- Regulation
- 886.1120
- Classification name
- Camera, Ophthalmic, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Related Records
Applicant Contact
- Contact
- Andrew DiGiore
- Address
- 145 Lexington Ave. Floor 10 New York NY US 10016 10016
FDA Registration Numbers
- 1319721
- 3005950902
- 3008396732
- 3003144120
- 2521877
- 1528142
- 3038614464
- 3012162565
- 3013403214
- 3016589969
- 3017175640
- 3010792309
- 3010363436
- 3010000450
- 9612197
- 2320749
- 2936921
- 3038790635
- 1316463
- 3008252121
- 1054713
- 3005755367
- 9614661
- 3009746052
- 3004443844
- 2080939
- 3010394097
- 2027009
- 3006087789
- 3011223751
- 3004441848
- 2242863
- 3004026651
- 3008729548
- 3005785090
- 3009173773
- 2918630
- 2020550
- 3006546174
- 3010069263
- 3002807715
- 3015316279
- 3003500271
- 3007237389
- 3009990264
- 3004848970
- 9616199
- 8010482
- 3007710608
- 3010202439
- 3015972897
- 3014606890
- 9617474
- 3003771740
- 8030392
- 3007913988
- 3008169506
- 1926681
- 3014342096
- 1000181430
- 1000391004
- 8020986
- 9615030
- 1222616
- 3012096560
- 3038356864
Source Documents
Other 510(k) Records For Product Code HKI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251353 | Eyer 2 | Phelcom Technologies | 2026-01-16 |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | 2025-12-12 |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025-09-04 |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025-08-14 |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | 2025-04-30 |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | 2024-12-09 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | 2024-05-15 |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023-12-05 |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | 2023-11-20 |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | 2023-09-06 |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023-03-15 |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023-02-22 |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | 2022-08-29 |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | 2021-04-13 |