Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K130704 |
Device Name |
MICRODOSE SI |
Applicant |
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
Smidesvagen 5 |
Solna,
SE
SE-171 41
|
|
Applicant Contact |
GUSTAV LINS |
Correspondent |
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
Smidesvagen 5 |
Solna,
SE
SE-171 41
|
|
Correspondent Contact |
GUSTAV LINS |
Regulation Number | 892.1715
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/2013 |
Decision Date | 12/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|