K043379 is an FDA 510(k) clearance for the SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on February 17, 2005, 71 days after receiving the submission on December 8, 2004.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K043379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2004 |
| Decision Date | February 17, 2005 |
| Days to Decision | 71 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| 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. |