K941363 is an FDA 510(k) clearance for the PHANTOM. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on July 20, 1994, 121 days after receiving the submission on March 21, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K941363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1994 |
| Decision Date | July 20, 1994 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |