GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS

FDA Premarket Approval P830074 S012

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 Received1987-06-10
Decision Date1987-11-25
PMAP830074
SupplementS012
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.