Submission Details
| 510(k) Number | K232082 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 2023 |
| Decision Date | February 13, 2024 |
| Days to Decision | 215 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
EXPD 4343S
Feb 2024
Decision
215d
Days
Class 2
Risk
About This 510(k) Submission
K232082 is an FDA 510(k) clearance for the EXPD 4343S, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by DRTECH Corporation (Gyeonggi-Do, KR). The FDA issued a Cleared decision on February 13, 2024, 215 days after receiving the submission on July 13, 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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