Premarket Approval (PMA)

Note: 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.

• Device: GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
• Generic Name: Full field digital, system, x-ray, mammographic
• Regulation Number: 892.1715
• Applicant: GE Healthcare; 3000 N. Grandview Blvd.; Waukesha, WI 53188
• PMA Number: P990066
• Supplement Number: S035
• Date Received: 01/14/2010
• Decision Date: 05/20/2010
• Reclassified Date: 12/06/2010
• Product Code: MUE
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE AMORPHOUS SILICON ARRAY DESIGN USED IN THE DETECTOR OF THE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE PROPOSED MODIFICATIONS INCLUDE THE FOLLOWING: 1) REDUCING THE NUMBER OF LAYERS IN THE DETECTOR AMORPHOUS SILICON ARRAY; 2) CHANGE IN THE DETECTOR FIRMWARE TO ALLOW THE DETECTOR CONFIGURATION TO BE COMMUNICATED TO THE SYSTEM IMAGE DETECTOR CONTROLLER (IDC); 3) IDC SOFTWARE TO AUTOMATICALLY DETERMINE IS A DETECTOR WITH THE PROPOSED MODIFICATION IS INSTALLED ON THE SYSTEM AND PROPERLY SELECT THE PROPER CONFIGURATION TABLE; AND 4) CORRESPONDING CHANGES IN THE INCOMING ACCEPTANCE CRITERIA TESTING STATION FOR THE MODIFIED DETECTOR.