510(k) K902044

MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM by Instrumentarium Imaging, Inc. — Product Code LNH

K902044 is an FDA 510(k) premarket notification submitted by Instrumentarium Imaging, Inc. for the device "MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Instrumentarium Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1990
Date Received
May 7, 1990
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