Device Classification Name |
Instrument, Quality-Assurance, Radiologic
|
510(k) Number |
K042733 |
Device Name |
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM |
Applicant |
STANDARD IMAGING, INC. |
7601 MURPHY DR. |
MIDDLETON,
WI
53562 -2766
|
|
Applicant Contact |
RAYMOND RIDDLE |
Correspondent |
STANDARD IMAGING, INC. |
7601 MURPHY DR. |
MIDDLETON,
WI
53562 -2766
|
|
Correspondent Contact |
RAYMOND RIDDLE |
Regulation Number | 892.1940
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/01/2004 |
Decision Date | 11/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|