K253495
- 510(k) number
- K253495
- Device name
- syngo.MR Applications (VB80)
- Applicant
- Siemens Healthineers AG DE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-11-20
- Date received
- 2025-10-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253495.pdf
Official FDA record: K253495
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.