Submission Details
| 510(k) Number | K171137 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 2017 |
| Decision Date | May 15, 2017 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EVS 2430W, EVS 2430GW
May 2017
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K171137 is an FDA 510(k) clearance for the EVS 2430W, EVS 2430GW, 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 May 15, 2017, 28 days after receiving the submission on April 17, 2017. 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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