Submission Details
| 510(k) Number | K192400 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 2019 |
| Decision Date | October 03, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
Oct 2019
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K192400 is an FDA 510(k) clearance for the EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by DRTECH Corporation (Jungwon-Gu, Seongam-Si, KR). The FDA issued a Cleared decision on October 3, 2019, 30 days after receiving the submission on September 3, 2019. 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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