ICAD SYSTEM

Analyzer, Medical Image

FDA Premarket Approval P010038 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 1) an upgraded algorithm for the icad system, 2) use of the icad system directly with images obtained on the fischer senoscan ffdm system, and 3) the new inclusion of women with breast implants in the target population in the indications for use (ifu). The device, as modified, will be marketed under the trade name icad system with the following indications for use: the icad is a computer system intended to identify and mark regions of interest on standard mammographic views, including views from cases for patients with breast implants and images from qualified full field digital mammography systems, 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: ICAD SYSTEM
• Classification Name: Analyzer, Medical Image
• Generic Name: Analyzer, Medical Image
• Applicant: ICAD, INC.
• Date Received: 2003-07-29
• Decision Date: 2003-10-31
• PMA: P010038
• Supplement: S005
• 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: ICAD, INC. 98 Spit Brook Road suite 100 nashua, NH 03062

Supplemental Filings

Supplement Number	Date	Supplement Type
P010038		Original Filing
S017	2012-10-05	Normal 180 Day Track
S016	2012-08-10	Normal 180 Day Track
S015	2008-05-19	Normal 180 Day Track No User Fee
S014	2007-04-02	Normal 180 Day Track No User Fee
S013	2006-12-18	Normal 180 Day Track
S012	2006-07-12	Normal 180 Day Track
S011
S010	2005-10-18	Normal 180 Day Track No User Fee
S009	2005-01-18	Normal 180 Day Track No User Fee
S008	2004-06-24	Normal 180 Day Track
S007	2004-04-28	Real-time Process
S006	2004-04-26	Normal 180 Day Track No User Fee
S005	2003-07-29	Normal 180 Day Track
S004	2003-06-18	Normal 180 Day Track
S003	2003-02-10	Normal 180 Day Track
S002	2002-10-28	Real-time Process
S001	2002-10-28	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00858012005007	P010038	012
00858012005830	P010038	013
00858012005823	P010038	013
00858012005809	P010038	013
00858012005175	P010038	013
00858012005168	P010038	013
00858012005151	P010038	013
00858012005144	P010038	013
00858012005137	P010038	013
00858012005120	P010038	013
00858012005113	P010038	013
00858012005106	P010038	013
00858012005847	P010038	013
00858012005861	P010038	013
00858012005014	P010038	013
00858012005854	P010038	013
00858012005816	P010038	013
00858012005793	P010038	013
00858012005601	P010038	013
00858012005083	P010038	013
00858012005076	P010038	013
00858012005052	P010038	013
00858012005038	P010038	013
00858012005021	P010038	013
00858012005090	P010038	013
00858012005069	P010038	016
00858012005045	P010038	017