K252133
- 510(k) number
- K252133
- Device name
- Adaptix Ortho350
- Applicant
- Adaptix Limited GB
- Product code
- IZF — System, X-Ray, Tomographic
- Decision date
- 2025-11-06
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252133.pdf
Official FDA record: K252133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.