# K170527: Phoenix Clinical ICON

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Technology Group, Inc. Dba Phoenix Clinical
- Decided: Sep 15, 2017 after 205 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 K081858 (2008). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102859: Retcam 3 Opthalmic Imaging System, Clarity Medical Systems (2011) Summary page 4.

## Most influential descendants
- K183059: 3nethra neo (2018), 1 descendant of its own
- K243600: 3nethra neo HD FA; 3nethra neo HD (2025), 0 descendants of its own
- K223575: Phoenix ICON, Phoenix ICON GO (2023), 0 descendants of its own

## Indications for use
General ophthalmic imaging including retinal, corneal, and external structures of the eye.

Source page: https://510kreport.com/device/K170527
Methodology: https://510kreport.com/methodology