K240371
- 510(k) number
- K240371
- Device name
- 0909FCC, 0909FCC-HS
- Applicant
- Rayence Co., Ltd. KR
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2024-03-07
- Date received
- 2024-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240371.pdf
Official FDA record: K240371
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.