IMAGE CHECKER M1000

FDA Premarket Approval P970058 S005

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

Approval for the addition of the canon model 300 digitizer as an optional digitizer for the imagechecker m1000.

DeviceIMAGE CHECKER M1000
Generic NameAnalyzer, Medical Image
ApplicantHOLOGIC, INC.
Date Received1999-09-08
Decision Date1999-10-05
PMAP970058
SupplementS005
Product CodeMYN 
Advisory CommitteeRadiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P970058Original Filing
S027 2016-01-20 Normal 180 Day Track No User Fee
S026 2013-10-17 Normal 180 Day Track
S025 2012-02-06 Normal 180 Day Track
S024 2006-09-18 Normal 180 Day Track No User Fee
S023
S022 2005-11-28 Normal 180 Day Track
S021 2004-11-19 Real-time Process
S020 2004-06-29 Normal 180 Day Track
S019 2004-03-01 Real-time Process
S018 2003-10-22 Real-time Process
S017 2003-07-08 Normal 180 Day Track
S016 2003-05-08 Normal 180 Day Track
S015 2002-10-22 Normal 180 Day Track
S014 2002-07-15 Normal 180 Day Track
S013 2002-02-19 Real-time Process
S012 2002-02-05 Normal 180 Day Track
S011 2001-09-28 Normal 180 Day Track
S010 2001-04-19 Normal 180 Day Track
S009 2000-12-08 Normal 180 Day Track
S008 2000-06-01 Normal 180 Day Track
S007 2000-01-28 Normal 180 Day Track
S006 2000-01-14 Normal 180 Day Track
S005 1999-09-08 Real-time Process
S004 1999-06-21 Normal 180 Day Track
S003 1998-12-16 Normal 180 Day Track
S002 1998-10-01 Normal 180 Day Track
S001 1998-09-29 Real-time Process

NIH GUDID Devices

Device IDPMASupp
15420045500037 P970058 026
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