K241249
- 510(k) number
- K241249
- Device name
- Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)
- Applicant
- Palodex Group OY FI
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2024-09-12
- Date received
- 2024-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241249.pdf
Official FDA record: K241249
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.