K242805
- 510(k) number
- K242805
- Device name
- Dental Cone-beam Computed Tomography (FinScan F350)
- Applicant
- Changzhou Finno Medical Technology Co., Ltd. CN
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2025-01-09
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242805.pdf
Official FDA record: K242805
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.