K241770
- 510(k) number
- K241770
- Device name
- Prostate MR AI (VA10A)
- Applicant
- Siemens Healthcare GmbH DE
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2025-03-05
- Date received
- 2024-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K241770.pdf
Official FDA record: K241770
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.