# K153283: VivoSight Dx Topical OCT System

- Pathway: 510(k) (Traditional)
- Applicant: Michelson Diagnostics, Ltd.
- Decided: Aug 11, 2016 after 273 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240610: deepLive (2024), 1 descendant of its own
- K252851: deepLive (OSP12 + DMS) (2025), 0 descendants of its own

## Indications for use
VivoSight Dx is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.

Source page: https://510kreport.com/device/K153283
Methodology: https://510kreport.com/methodology