# K063837: Sigma M

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Dental, Palodex Group OY
- Decided: Jul 2, 2007 after 188 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081925: Snapshot (2008), 1 descendant of its own
- K173646: FS Ergo (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K063837
Methodology: https://510kreport.com/methodology