510(k) K250738
K250738 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions for the device "YSIO X.pree". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Siemens Medical Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2025
- Date Received
- March 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type