510(k) K190757
K190757 is an FDA 510(k) premarket notification submitted by Siemens Medical Solution USA, Inc. for the device "MAGNETOM Avanto Fit". The FDA issued a decision of Substantially Equivalent on May 31, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Solution USA, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2019
- Date Received
- Mar 25, 2019
- 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
- 510(k)