K242731 is an FDA 510(k) clearance for the MasteRad MiniX Mobile Digital Imaging System (Mini-X). This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Medicatech USA, Inc. (Irvine, US). The FDA issued a Cleared decision on May 16, 2025, 248 days after receiving the submission on September 10, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K242731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2024 |
| Decision Date | May 16, 2025 |
| Days to Decision | 248 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 |