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.
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.
| Device | ACHILLES INSIGHT ULTRASONOMETER |
| Generic Name | Bone Sonometer |
| Applicant | GE LUNAR CORP. |
| Date Received | 2001-05-07 |
| Decision Date | 2001-10-24 |
| PMA | P970040 |
| Supplement | S002 |
| Product Code | MUA |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GE LUNAR CORP. 726 Heartland Trail madison, WI 53717 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970040 | Original 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 |