# K211542: Primo S

- Pathway: 510(k) (Traditional)
- Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.
- Decided: Jul 9, 2021 after 51 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T, Sedecal., Sa. (2013) Summary page 4.

## Indications for use
Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

Source page: https://510kreport.com/device/K211542
Methodology: https://510kreport.com/methodology