|
Device | ACHILLES INSIGHT ULTRASONOMETER |
Generic Name | Bone sonometer |
Regulation Number | 892.1180 |
Applicant | GE LUNAR CORP. 726 HEARTLAND TRAIL MADISON, WI 53717 |
PMA Number | P970040 |
Supplement Number | S002 |
Date Received | 05/07/2001 |
Decision Date | 10/24/2001 |
Reclassified Date
|
08/18/2008 |
Product Code |
MUA |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |