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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceMOBILE SENOGRAPHE 2000D
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
GE Healthcare
3000 n. grandview blvd
waukesha, WI 53188
PMA NumberP990066
Supplement NumberS008
Date Received10/26/2001
Decision Date12/18/2001
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO MAKE A MOBILE VERSION OF THE DEVICE, THAT IS CAPABLE OF MOVING FROM PLACE TO PLACE IN AN AIR-RIDE VAN AND ABLE TO TRANSMIT IMAGES FROM THESE LOCATIONS VIA A WIRELESS COMMUNICATIONS LINK.
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