K230985
- 510(k) number
- K230985
- Device name
- Planmeca Viso
- Applicant
- Planmeca Oy FI
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2023-12-28
- Date received
- 2023-04-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230985.pdf
Official FDA record: K230985
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.