Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K071636 |
Device Name |
CODIAGNOSTIX (R) 5.72 |
Applicant |
IVS SOLUTIONS AG |
ANNABERGET STRASSE 240 |
CHEMNITZ, SAXONY,
DE
09125
|
|
Applicant Contact |
FRANK STOCKMANN |
Correspondent |
IVS SOLUTIONS AG |
ANNABERGET STRASSE 240 |
CHEMNITZ, SAXONY,
DE
09125
|
|
Correspondent Contact |
FRANK STOCKMANN |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/15/2007 |
Decision Date | 08/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|