Submission Details
| 510(k) Number | K193017 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
Nov 2019
Decision
24d
Days
Class 2
Risk
About This 510(k) Submission
K193017 is an FDA 510(k) clearance for the EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP, 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 November 22, 2019, 24 days after receiving the submission on October 29, 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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