MAGNISCAN 5000 MRI SYSTEM

FDA Premarket Approval P850043 S002

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

DeviceMAGNISCAN 5000 MRI SYSTEM
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantTHOMSON-CGR MEDICAL CORP.
Date Received1987-09-01
Decision Date1987-12-29
PMAP850043
SupplementS002
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address THOMSON-CGR MEDICAL CORP. 10150 Old Columbia Rd. columbia, MD 21046

Supplemental Filings

Supplement NumberDateSupplement Type
P850043Original Filing
S002 1987-09-01 Normal 180 Day Track
S001 1987-08-07 Normal 180 Day Track

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