ACHILLES INSIGHT ULTRASONOMETER

FDA Premarket Approval P970040 S002

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.

Pre-market Approval Supplement Details

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.

DeviceACHILLES INSIGHT ULTRASONOMETER
Generic NameBone Sonometer
ApplicantGE LUNAR CORP.
Date Received2001-05-07
Decision Date2001-10-24
PMAP970040
SupplementS002
Product CodeMUA 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GE LUNAR CORP. 726 Heartland Trail madison, WI 53717

Supplemental Filings

Supplement NumberDateSupplement Type
P970040Original Filing
S003 2004-07-15 Normal 180 Day Track No User Fee
S002 2001-05-07 Normal 180 Day Track
S001 1999-02-16 Real-time Process

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