Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K122260 |
Device Name |
AYCAN MOBILE |
Applicant |
AYCAN DIGITALSYSTEME GMBH |
INNERE AUMUEHL STRASSE 5 |
WUERZBURG,
DE
97076
|
|
Applicant Contact |
MATTHIAS BROENNER |
Correspondent |
AYCAN DIGITALSYSTEME GMBH |
INNERE AUMUEHL STRASSE 5 |
WUERZBURG,
DE
97076
|
|
Correspondent Contact |
MATTHIAS BROENNER |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 09/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|