K242394
- 510(k) number
- K242394
- Device name
- Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
- Applicant
- Rayence Co., Ltd. KR
- Product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Decision date
- 2024-09-09
- Date received
- 2024-08-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242394.pdf
Official FDA record: K242394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.