K142930 is an FDA 510(k) clearance for the Exam Vue DR. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Jpi Healthcare Co, Ltd. (Kuro 3-Dong, Kuro_Gu, KR). The FDA issued a Cleared decision on April 17, 2015, 190 days after receiving the submission on October 9, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K142930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2014 |
| Decision Date | April 17, 2015 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |