GYREX, MODELS S3500 & S5000

FDA Premarket Approval P840007 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

DeviceGYREX, MODELS S3500 & S5000
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantELSCINT, INC.
Date Received1987-07-01
Decision Date1987-10-08
PMAP840007
SupplementS002
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ELSCINT, INC. 930 Commonwealth Ave. boston, MA 02215

Supplemental Filings

Supplement NumberDateSupplement Type
P840007Original Filing
S003 1988-01-29 Normal 180 Day Track
S002 1987-07-01 Normal 180 Day Track
S001 1986-12-31 Normal 180 Day Track

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