K981131 is an FDA 510(k) clearance for the PATHFINDER MOBILE C ARM. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 26, 1998, 88 days after receiving the submission on March 30, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K981131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1998 |
| Decision Date | June 26, 1998 |
| Days to Decision | 88 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. |