510(k) K192690
K192690 is an FDA 510(k) premarket notification submitted by Asg Superconductors S.P.A. for the device "Upgrade Kit MR GUI PRO, MrJ 3300 Plus". The FDA issued a decision of Substantially Equivalent on October 24, 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
- October 24, 2019
- Date Received
- September 26, 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