# K211777: Arco FP-S

- Pathway: 510(k) (Traditional)
- Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.
- Decided: Aug 13, 2021 after 65 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K182086 (2019). 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)
- K182086: Arco FP, A.T.S. Applicazione Tecnologie Speciali S.R.L. (2019) Summary page 4.

## Indications for use
ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.

Source page: https://510kreport.com/device/K211777
Methodology: https://510kreport.com/methodology