510(k) K231560
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit by
Siemens Medical Solutions USA, Inc.
— Product Code LNH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2023
- Date Received
- May 30, 2023
- 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