K182086 is an FDA 510(k) clearance for the ARCO FP. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by A.T.S. Applicazione Tecnologie Speciali S.R.L. (Torre De’ Roveri, IT). The FDA issued a Cleared decision on August 20, 2019, 383 days after receiving the submission on August 2, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K182086 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2018 |
| Decision Date | August 20, 2019 |
| Days to Decision | 383 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |