K230998
- 510(k) number
- K230998
- Device name
- Digital Wireless Intraoral X-Ray Sensor
- Applicant
- Iray Imaging Technology (Haining) Limited CN
- Product code
- MUH — System, X-Ray, Extraoral Source, Digital
- Decision date
- 2023-10-20
- Date received
- 2023-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230998.pdf
Official FDA record: K230998
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.