510(k) K221619
K221619 is an FDA 510(k) premarket notification submitted by Fujifilm Healthcare Corporation for the device "ECHELON Oval V6.2 MRI System". The FDA issued a decision of Substantially Equivalent on January 26, 2023. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Fujifilm Healthcare Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2023
- Date Received
- June 3, 2022
- 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