# K223381: iExaminer System with Panoptic Plus

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Mar 15, 2023 after 128 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003376 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121405: Panoptic, Welch Allyn, Inc. (2012) Summary page 5.

## Indications for use
The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartBracket, SmartClip, iExaminer application, and one of the following: iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.

Source page: https://510kreport.com/device/K223381
Methodology: https://510kreport.com/methodology