K945707 is an FDA 510(k) clearance for the MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Minxray, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 19, 1995, 59 days after receiving the submission on November 21, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K945707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1994 |
| Decision Date | January 19, 1995 |
| Days to Decision | 59 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 |