FDA Product Code HKI: Camera, Ophthalmic, Ac-powered
Leading manufacturers include Welch Allyn, Inc. and Canon, Inc..
2
Total
2
Cleared
78d
Avg days
2023
Since
List of Camera, Ophthalmic, Ac-powered devices cleared through 510(k)
2 devices
Cleared
May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
Canon, Inc.
Ophthalmic
28d
Cleared
Mar 15, 2023
iExaminer System with Panoptic Plus
Welch Allyn, Inc.
Ophthalmic
128d
How to use this database
This page lists all FDA 510(k) submissions for Camera, Ophthalmic, Ac-powered devices (product code HKI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ophthalmic FDA review panel. Browse all Ophthalmic devices →