Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sentinel Camera

K-Number: K243664 · 2024-12-17

ApplicantAi Optics
Decision Date2024-12-17
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Sentinel Camera is the device name listed in this FDA 510(k) record. The listed applicant is Ai Optics. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K243664. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sentinel Camera?

Sentinel Camera is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Ai Optics. The 510(k) number is K243664.

When did Sentinel Camera receive FDA 510(k) clearance?

Sentinel Camera received FDA 510(k) clearance on 2024-12-17, under 510(k) number K243664.

Who is the listed applicant for Sentinel Camera?

The FDA 510(k) record lists Ai Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sentinel Camera?

The FDA product code for Sentinel Camera is HKI.

Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑