K232552
- 510(k) number
- K232552
- Device name
- TuxDeluxe (Size 1 6100B, Size 2 6101B)
- Applicant
- Tuxedo Imaging, LLC OH · US
- Product code
- MUH — System, X-Ray, Extraoral Source, Digital
- Decision date
- 2023-10-20
- Date received
- 2023-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232552.pdf
Official FDA record: K232552
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.