510(k) K173382
K173382 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Vantage Galan 3T, V4.6". The FDA issued a decision of Substantially Equivalent on Jan 26, 2018. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 2018
- Date Received
- Oct 30, 2017
- 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
- 510(k)