K153059 is an FDA 510(k) clearance for the HF1202H PowerPlus Portable X-ray Equipment. 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 February 2, 2016, 104 days after receiving the submission on October 21, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K153059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2015 |
| Decision Date | February 02, 2016 |
| Days to Decision | 104 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 |