510(k) K242258
K242258 is an FDA 510(k) premarket notification submitted by Asg Superconductors S.P.A. for the device "MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)". The FDA issued a decision of Substantially Equivalent on November 26, 2024. 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
- November 26, 2024
- Date Received
- July 31, 2024
- 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