# K121405: Panoptic

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Dec 20, 2012 after 224 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: 3 generations back to K003376 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110986: Optomed Smartscope M5 EY3 and M5 ES1, Optomed OY (2011) Summary page 1.
- K080681: Kowa Genesis-D, Kowa Co., Ltd. (2008) Summary page 1.
- K102412: Vista Digital Opthalmoscope, Eyequick.Llc (2011) Summary page 1.
- K003376: Welch Allyn 11800 Opthalmoscope, Welch Allyn, Inc. (2001) Summary page 1.

## Most influential descendants
- K223381: iExaminer System with Panoptic Plus (2023), 0 descendants of its own

## Indications for use
The iExaminer is an attachment and software used only with the iPhone 4 and iPhone 4S in conjunction with the Welch Allyn PanOptic Ophthalmoscope to allow users to capture, send, store and retrieve images of the eye. The device is intended to be used by trained personnel within a medical or school environment.

Source page: https://510kreport.com/device/K121405
Methodology: https://510kreport.com/methodology