# K151053: PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner

- Pathway: 510(k) (Traditional)
- Applicant: Sopro - Acteon Group
- Decided: Jul 31, 2015 after 102 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.

Source page: https://510kreport.com/device/K151053
Methodology: https://510kreport.com/methodology