IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

FDA Premarket Approval P970058 S022

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 of new labeling that will present the specificity of cad marks generated by r2 imagechecker computer aided detection system as well as its ability to mark actionable priors. The indications for use remain as previously approved: the imagechecker m5000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

• Device: IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
• Generic Name: Analyzer, Medical Image
• Applicant: HOLOGIC, INC.
• Date Received: 2005-11-28
• Decision Date: 2006-06-23
• PMA: P970058
• Supplement: S022
• Product Code: MYN
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• 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