K200218 is an FDA 510(k) clearance for the Digiscan FDX. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Allengers Medical Systems Limited (Derabassi, Distt Mohali, IN). The FDA issued a Cleared decision on July 13, 2020, 167 days after receiving the submission on January 28, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K200218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2020 |
| Decision Date | July 13, 2020 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |