Submission Details
| 510(k) Number | K193031 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EXPD 4343P, EXPD 3643P
Nov 2019
Decision
23d
Days
Class 2
Risk
About This 510(k) Submission
K193031 is an FDA 510(k) clearance for the EXPD 4343P, EXPD 3643P, 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, 23 days after receiving the submission on October 30, 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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