Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K110717 |
Device Name |
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM |
Applicant |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
25 WALNUT STREET |
MONROE,
CT
06468
|
|
Applicant Contact |
JILLIAN M REED |
Correspondent |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
25 WALNUT STREET |
MONROE,
CT
06468
|
|
Correspondent Contact |
JILLIAN M REED |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 03/15/2011 |
Decision Date | 12/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|