510(k) K171597
K171597 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Vantage Elan 1.5T, V4.0". The FDA issued a decision of Substantially Equivalent on Jul 21, 2017. 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
- Jul 21, 2017
- Date Received
- May 31, 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)