K231396
- 510(k) number
- K231396
- Device name
- CEPHX- Cephalometric Analysis Software
- Applicant
- Orca Dental AI , Ltd. IL
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-01-31
- Date received
- 2023-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231396.pdf
Official FDA record: K231396
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.