# K201408: Demetra Analytics Toolkit

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Feb 18, 2021 after 266 days
- Product code: PSN (Light Based 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: 2 generations back to K023729 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062736: Siascope V, Astron Clinica Limited (2007) Summary page 4.

## Indications for use
The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco Demetra Skin Parameter Maps Tool provides maps that show the relative location of blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to complement dermoscopy.

Source page: https://510kreport.com/device/K201408
Methodology: https://510kreport.com/methodology