This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the qus-2 calcaneal ultrasonometer. The qus-2 ultrasonometer is a medical device that utilizes quantitative ultrasound for evaluation of the calcaneus. Its bua (broadband ultrasound attenuation) value is intended to be used as an aid in the diagnosis of osteoporosis and in the determination of risk of subsequent atraumatic fracture.
| Device | QUS-2 (TM) CALCANEAL ULTRASONOMETER |
| Classification Name | Tester, Acoustic, Bone Quality |
| Generic Name | Tester, Acoustic, Bone Quality |
| Applicant | QUIDEL CORP. |
| Date Received | 1999-07-14 |
| Decision Date | 2000-08-01 |
| Notice Date | 2000-08-16 |
| PMA | P990039 |
| Supplement | S |
| Product Code | NAN |
| Docket Number | 00M-1437 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QUIDEL CORP. 2981 Copper Rd. santa Clara, CA |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990039 | Original Filing | |
| S001 | 2003-04-14 | Normal 180 Day Track No User Fee |