K213057 is an FDA 510(k) clearance for the ExamVue Duo. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Jpi Healthcare Co, Ltd. (Seoul, KR). The FDA issued a Cleared decision on February 18, 2022, 149 days after receiving the submission on September 22, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K213057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2021 |
| Decision Date | February 18, 2022 |
| Days to Decision | 149 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 |