# K201552: ApolloVue S100 Image System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Medical Optics, Ltd.
- Decided: Sep 2, 2020 after 84 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093520 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093520: Vivosight Topical Oct System, Michelson Diagnostics, Ltd. (2010) Summary page 5.

## Indications for use
ApolloVue S100 Image System is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.

Source page: https://510kreport.com/device/K201552
Methodology: https://510kreport.com/methodology