PMA P970040S002

Device: ACHILLES INSIGHT ULTRASONOMETER
Applicant: Ge Lunar Corp.
PMA number: P970040
Supplement: S002
Product code: MUA
Decision date: 2001-10-24
Generic name: Bone sonometer
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.

Current openFDA PMA Record#

Device: ACHILLES INSIGHT ULTRASONOMETER
Applicant: Ge Lunar Corp.
PMA number: P970040
Supplement: S002
Product code: MUA
Generic name: Bone sonometer
Decision date: 2001-10-24
Decision code: APPR
Date received: 2001-05-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.