K250211
- 510(k) number
- K250211
- Device name
- Yushan X-Ray Flat Panel Detector
- Applicant
- Innocare Optoelectronics Corp. TW
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2025-07-22
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250211.pdf
Official FDA record: K250211
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.