510(k) K193116
K193116 is an FDA 510(k) premarket notification submitted by Asg Superconductors S.P.A. for the device "MRopen EVO". The FDA issued a decision of Substantially Equivalent on December 20, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Asg Superconductors S.P.A. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2019
- Date Received
- November 12, 2019
- Clearance Type
- Special
- 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