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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.
 
DeviceACHILLES INSIGHT ULTRASONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantGe Lunar Corp.
726 Heartland Trl.
Madison, WI 53717
PMA NumberP970040
Supplement NumberS002
Date Received05/07/2001
Decision Date10/24/2001
Reclassified Date08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) THE ADDITION OF 2-D REAL TIME PREVIEW IMAGING; 2) A NEW RECEIVER TRANSDUCER ARRAY; 3) HIGHER CONTRAST COLOR LCD GRAPHICS AND IMAGING; AND 4) AN OPTIONAL LARGER SCREEN DISPLAY.
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