K232158
- 510(k) number
- K232158
- Device name
- GenX-CR
- Applicant
- Genoray Co., Ltd. KR
- Product code
- MUH — System, X-Ray, Extraoral Source, Digital
- Decision date
- 2023-09-13
- Date received
- 2023-07-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232158.pdf
Official FDA record: K232158
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.