Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K111324 |
Device Name |
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER |
Applicant |
AGFA HEALTHCARE N.V. |
10 S ACADEMY STREET |
GREENVILLE,
SC
29601
|
|
Applicant Contact |
PHIL CUSCUNA |
Correspondent |
AGFA HEALTHCARE N.V. |
10 S ACADEMY STREET |
GREENVILLE,
SC
29601
|
|
Correspondent Contact |
PHIL CUSCUNA |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 05/11/2011 |
Decision Date | 12/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|