K921255 is an FDA 510(k) clearance for the PHILIPS BV26 MOBILE C-ARM STAND. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on May 18, 1992, 63 days after receiving the submission on March 16, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K921255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1992 |
| Decision Date | May 18, 1992 |
| Days to Decision | 63 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. |