GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS

FDA Premarket Approval P830074 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceGE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantGENERAL ELECTRIC CO.
Date Received1986-12-23
Decision Date1987-03-30
PMAP830074
SupplementS010
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address GENERAL ELECTRIC CO. p0 Box 414 milwaukee, WI 

Supplemental Filings

Supplement NumberDateSupplement Type
P830074Original Filing
S017 1988-07-18 30-Day Supplement
S016 1988-02-12 Normal 180 Day Track
S015 1988-01-13 Normal 180 Day Track
S014 1987-12-18 Normal 180 Day Track
S013 1987-08-25 Normal 180 Day Track
S012 1987-06-10 Normal 180 Day Track
S011 1987-03-18 Normal 180 Day Track
S010 1986-12-23 Normal 180 Day Track
S009 1986-10-22 Normal 180 Day Track
S008
S007 1985-12-20
S006 1985-11-14
S005 1985-09-12
S004 1985-06-21
S003 1985-05-30
S002 1985-05-21
S001 1985-04-29

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