K052721 is an FDA 510(k) clearance for the MINXRAY, MODEL HF100H+. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Minxray, Inc. (Deer Field, US). The FDA issued a Cleared decision on October 27, 2005, 28 days after receiving the submission on September 29, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K052721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2005 |
| Decision Date | October 27, 2005 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL - System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |