510(k) K984224

PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS by Siemens Corp. — Product Code LNH

K984224 is an FDA 510(k) premarket notification submitted by Siemens Corp. for the device "PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 2, 1999. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 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