# K232789: VIO System (V-1000)

- Pathway: 510(k) (Traditional)
- Applicant: Enspectra Health, Inc.
- Decided: Dec 22, 2023 after 102 days
- Product code: QZN (Multi-Photon Imaging)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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 K180162 (2018). 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)
- K180162: VivaScope System, Caliber Imaging & Diagnostics, Inc. (2018) Summary page 5.

## Indications for use
The VIO System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue – including blood vessels, collagen, pigment, stratum corneum, hair shafts or follicles, solar elastosis, hyperkeratosis, atypia, and epidermal disarray – in and through epidermis for review by physicians to assist in forming a clinical judgment. Physicians who interpret VIO System images must have dermatology or pathology medical qualifications with skin histology assessment training.

Source page: https://510kreport.com/device/K232789
Methodology: https://510kreport.com/methodology