K253800
- 510(k) number
- K253800
- Device name
- 0909FCE, 0909FCE-HS
- Applicant
- Rayence Co., Ltd. KR
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2026-07-31
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253800.pdf
Official FDA record: K253800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.