# K092329: SOPIX 2

- Pathway: 510(k) (Traditional)
- Applicant: Sopro
- Decided: Jul 20, 2010 after 350 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
Longest line of descent: 1 generation back to K050693 (2005). 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)
- K050693: Accent, Air Techniques, Inc. (2005) Summary page 1.

## Indications for use
The SOPIX 2 SYSTEM is intended to be used by qualified dentist in general to provide instant X-Ray images, typically of tooth, bone and surrounding tissues.

Source page: https://510kreport.com/device/K092329
Methodology: https://510kreport.com/methodology