K933447 is an FDA 510(k) clearance for the STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on August 23, 1993, 41 days after receiving the submission on July 13, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K933447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1993 |
| Decision Date | August 23, 1993 |
| Days to Decision | 41 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. |