K980322 is an FDA 510(k) clearance for the ACCENT 16, ACCENT 22. 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 (Waukesha, US). The FDA issued a Cleared decision on April 24, 1998, 87 days after receiving the submission on January 27, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K980322 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1998 |
| Decision Date | April 24, 1998 |
| Days to Decision | 87 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. |