Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K152977 |
Device Name |
DG PACS |
Applicant |
DICOM GRID, INC. |
4530 E MUIRWOOD DRIVE, SUITE 113 |
PHOENIX,
AZ
85048
|
|
Applicant Contact |
LAUREN STILL |
Correspondent |
DICOM GRID, INC. |
PHOENIX,
AZ
85048
|
|
Correspondent Contact |
CALLEY HERZOG |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/08/2015 |
Decision Date | 01/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|