Submission Details
| 510(k) Number | K162555 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 2016 |
| Decision Date | December 21, 2016 |
| Days to Decision | 99 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EVS 4343, EVS 4343G
Dec 2016
Decision
99d
Days
Class 2
Risk
About This 510(k) Submission
K162555 is an FDA 510(k) clearance for the EVS 4343, EVS 4343G, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on December 21, 2016, 99 days after receiving the submission on September 13, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | MQB — Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
Manufacturer
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