Submission Details
| 510(k) Number | K231959 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2023 |
| Decision Date | August 01, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EXPD 4357; EXPD 4357P
Aug 2023
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K231959 is an FDA 510(k) clearance for the EXPD 4357; EXPD 4357P, 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 August 1, 2023, 29 days after receiving the submission on July 3, 2023. 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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