K252608
- 510(k) number
- K252608
- Device name
- AI-Rad Companion Prostate MR
- Applicant
- Siemens Healthcare GmbH DE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-09-09
- Date received
- 2025-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252608.pdf
Official FDA record: K252608
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.