510(k) K191662
K191662 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Vantage Orian 1.5T, MRT-1550, V4.5". The FDA issued a decision of Substantially Equivalent on Jul 23, 2019. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2019
- Date Received
- Jun 21, 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
- 510(k)