# K213957: Demetra Dermatoscope BDEM-01

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Mar 11, 2022 after 84 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: 4 generations back to K010259 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192829: Demetra BDEM-01 Dermatoscope, Barco N.V. (2019) Summary page 4.

## Indications for use
The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

Source page: https://510kreport.com/device/K213957
Methodology: https://510kreport.com/methodology