# K093520: Vivosight Topical Oct System

- Pathway: 510(k) (Traditional)
- Applicant: Michelson Diagnostics, Ltd.
- Decided: Jan 5, 2010 after 53 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Imalux OCT Imaging System: named in the summary without a submission number

## Most influential descendants
- K133209: Foresee (4C) Imaging System (2014), 1 descendant of its own
- K242924: OPXION Optical Skin Viewer (OPXSV1-01F) (2025), 0 descendants of its own
- K201552: ApolloVue S100 Image System (2020), 0 descendants of its own
- K191804: TOMi Scope (2019), 0 descendants of its own
- K132800: Skintell (2014), 0 descendants of its own

## Indications for use
VivoSight 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/K093520
Methodology: https://510kreport.com/methodology