Sentinel Camera
FDA 510(k) K243664 · Ai Optics
510(k) numberK243664
Submission
- Device name
- Sentinel Camera
- Applicant
- Ai Optics
New York, NY, US - Received
- November 27, 2024
- Decision date
- December 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
Other 510(k)s with product code HKI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253176 | TearViewHKI · Traditional | Beyond 700 Pty, Ltd. | 06/22/2026SE |
| K251353 | Eyer 2HKI · Traditional | Phelcom Technologies | 01/16/2026SE |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10)HKI · Traditional | Remidio Innovative Solutions Private Limited | 12/12/2025SE |
| K250770 | Optina-4C (MHRC-C1N)HKI · Traditional | Optina Diagnostics, Inc. | 09/04/2025SE |
| K243600 | 3nethra neo HD FA; 3nethra neo HDHKI · Traditional | Forus Health Pvt.Ltd | 08/14/2025SE |
| K250683 | Resolve Fundus CameraHKI · Traditional | Optain Health, Inc. | 04/30/2025SE |
| K242508 | Verily Numetric Retinal CameraHKI · Traditional | Verily Life Sciences, LLC | 12/09/2024SE |
| K241049 | CANON Fundus Camera CR-10 (CR-10)HKI · Special | Canon, Inc. | 05/15/2024SE |
| K231230 | Optina-4C (MHRC-C1N)HKI · Special | Optina Diagnostics, Inc. | 12/05/2023SE |
| K230627 | Zilia Ocular FC (ZIL-10002)HKI · Traditional | Zilia, Inc. | 11/20/2023SE |
Questions and answers
When was Sentinel Camera cleared by the FDA?
Sentinel Camera (K243664) received a 510(k) decision of Substantially Equivalent on December 17, 2024, 20 days after the submission was received.
What is the product code of K243664?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.