K243452 is an FDA 510(k) clearance for the Orthoscan VERSA Mini C-Arm. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Ziehm-Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on January 14, 2025, 68 days after receiving the submission on November 7, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K243452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2024 |
| Decision Date | January 14, 2025 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OXO - Image-intensified Fluoroscopic X-ray System, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Fluoroscopy Of The Human Body. |