Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K081752 |
Device Name |
EDGE PACS |
Applicant |
ASHVA TECHNOLOGIES, PVT. LTD |
1600 MANCHESTER WAY |
CORINTH,
TX
76210
|
|
Applicant Contact |
CARL ALLETTO |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/20/2008 |
Decision Date | 08/06/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|