510(k) K250436
K250436 is an FDA 510(k) premarket notification submitted by Siemens Shenzhen Magnetic Resonance , Ltd. for the device "MAGNETOM Flow.Ace; MAGNETOM Flow.Plus". The FDA issued a decision of Substantially Equivalent on June 16, 2025. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Shenzhen Magnetic Resonance , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2025
- Date Received
- February 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type