Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K042313 |
Device Name |
INTEGRADWEB MPR/MIP |
Applicant |
DYNAMIC IMAGING INC. |
1100 LAKEVIEW BLVD. |
DENTON,
TX
76208
|
|
Applicant Contact |
CARL ALLETTO |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/26/2004 |
Decision Date | 09/09/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|