K172928 is an FDA 510(k) clearance for the Portable X-ray System. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Rolence Enterprise, Inc. (Taoyuan, TW). The FDA issued a Cleared decision on March 16, 2018, 172 days after receiving the submission on September 25, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K172928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2017 |
| Decision Date | March 16, 2018 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |