K240642
- 510(k) number
- K240642
- Device name
- SMART Bun-Yo-Matic CT
- Applicant
- Disior, Ltd. FI
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-06-20
- Date received
- 2024-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240642.pdf
Official FDA record: K240642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.