Device Classification Name |
densitometer, bone
|
510(k) Number |
K072847 |
Device Name |
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS |
Applicant |
HOLOGIC, INC. |
35 CROSBY DR. |
BEDFORD,
MA
01730
|
|
Applicant Contact |
BRYAN COWELL |
Correspondent |
HOLOGIC, INC. |
35 CROSBY DR. |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
BRYAN COWELL |
Regulation Number | 892.1170
|
Classification Product Code |
|
Date Received | 10/04/2007 |
Decision Date | 03/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|