# K240610: deepLive

- Pathway: 510(k) (Traditional)
- Applicant: Damae Medical
- Decided: Jul 9, 2024 after 126 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 K153283 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153283: VivoSight Dx Topical OCT System, Michelson Diagnostics, Ltd. (2016) Summary page 4.

## Most influential descendants
- K252851: deepLive (OSP12 + DMS) (2025), 0 descendants of its own

## Indications for use
deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-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/K240610
Methodology: https://510kreport.com/methodology