510(k) K102489

VANTAGE TITAN 3T by Toshiba Medical Systems Corporation, Japan — Product Code LNH

K102489 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "VANTAGE TITAN 3T". The FDA issued a decision of Substantially Equivalent on Aug 2, 2011. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 2, 2011
Date Received
Aug 31, 2010
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)