DIASONICS NMR IMAGING SYSTEM

FDA Premarket Approval P830053 S027

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

DeviceDIASONICS NMR IMAGING SYSTEM
Generic NameSystem, Nuclear Magnetic Resonance Imaging
ApplicantDIASONICS, INC.
Date Received1987-04-01
Decision Date1987-06-22
PMAP830053
SupplementS027
Product CodeLNH 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DIASONICS, INC. 533 Cabot Rd. s. San Francisco, CA 94080

Supplemental Filings

Supplement NumberDateSupplement Type
P830053Original Filing
S030 1988-06-06 Normal 180 Day Track
S029 1988-04-18 Normal 180 Day Track
S028 1988-02-02 30-Day Supplement
S027 1987-04-01 Normal 180 Day Track
S026 1987-03-19 30-Day Supplement
S025 1987-02-19 Normal 180 Day Track
S024 1986-11-19 Normal 180 Day Track
S023 1986-10-07 Normal 180 Day Track
S022 1986-09-12 Normal 180 Day Track
S021 1986-09-17 Normal 180 Day Track
S020 1986-09-02 30-Day Supplement
S019 1986-05-13
S018 1986-03-12
S017
S016 1985-11-26
S015 1985-10-09
S014 1985-10-07
S013 1985-05-23
S012 1985-04-11
S011 1985-04-01
S010 1985-02-22
S009 1985-02-22
S008 1985-01-10
S007 1984-12-24
S006 1984-12-13
S005
S004 1984-10-05
S003 1984-08-22
S002
S001 1984-06-19

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