510(k) K984221

FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR by Siemens Corp. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1999
Date Received
November 25, 1998
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