Submission Details
| 510(k) Number | K142475 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 2014 |
| Decision Date | January 15, 2015 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
EVS 4343
Jan 2015
Decision
134d
Days
Class 2
Risk
About This 510(k) Submission
K142475 is an FDA 510(k) clearance for the EVS 4343, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by DRTECH Corporation (Seongam-Si, KR). The FDA issued a Cleared decision on January 15, 2015, 134 days after receiving the submission on September 3, 2014. 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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