# K182086: Arco FP

- Pathway: 510(k) (Traditional)
- Applicant: A.T.S. Applicazione Tecnologie Speciali S.R.L.
- Decided: Aug 20, 2019 after 383 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250282: Persona C HR (2025), 0 descendants of its own
- K211777: Arco FP-S (2021), 0 descendants of its own

## Indications for use
ARCO FP is a mobile x-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures. Arco FP device can be used on all patients except pediatric patients within the limits of the device.

Source page: https://510kreport.com/device/K182086
Methodology: https://510kreport.com/methodology