|
Device | QUS-2 (TM) CALCANEAL ULTRASONOMETER |
Generic Name | Tester, acoustic, bone quality |
Applicant | QUIDEL CORP. 2981 COPPER RD. SANTA CLARA, CA |
PMA Number | P990039 |
Date Received | 07/14/1999 |
Decision Date | 08/01/2000 |
Withdrawal Date
|
10/08/2010 |
Product Code |
NAN |
Docket Number | 00M-1437 |
Notice Date | 08/16/2000 |
Advisory Committee |
Radiology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Supplements: |
S001 |