K232082
- 510(k) number
- K232082
- Device name
- EXPD 4343S
- Applicant
- DRTECH Corporation KR
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2024-02-13
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232082.pdf
Official FDA record: K232082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.