Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K142037 |
Device Name |
QUANTRA |
Applicant |
HOLOGIC, INC. |
2585 AUGUSTINE DR |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
CATHERINE WILLIAMS |
Correspondent |
HOLOGIC, INC. |
2585 AUGUSTINE DR |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
CATHERINE WILLIAMS |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/28/2014 |
Decision Date | 10/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|