IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

FDA Premarket Approval P970058 S020

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 improvements in the cad detection algorithm and the introduction of more choice in operating points for both analog and digital images.

• Device: IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0
• Generic Name: Analyzer, Medical Image
• Applicant: HOLOGIC, INC.
• Date Received: 2004-06-29
• Decision Date: 2005-02-17
• PMA: P970058
• Supplement: S020
• Product Code: MYN
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730

Supplemental Filings

Supplement Number	Date	Supplement Type
P970058		Original 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 ID	PMA	Supp
15420045500037	P970058	026