K240036
- 510(k) number
- K240036
- Device name
- PIUR tUS Infinity
- Applicant
- Piur Imaging GmbH AT
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-09-20
- Date received
- 2024-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K240036.pdf
Official FDA record: K240036
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.