Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K120718 |
Device Name |
INSTAPACS/INSTARISPACS |
Applicant |
MEDDIFF TECHNOLOGIES PVT. LTD |
1600 MANCHESTER WAY |
CORINTH,
TX
76210
|
|
Applicant Contact |
CARL ALLETTO |
Correspondent |
MEDDIFF TECHNOLOGIES PVT. LTD |
1600 MANCHESTER WAY |
CORINTH,
TX
76210
|
|
Correspondent Contact |
CARL ALLETTO |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/08/2012 |
Decision Date | 04/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|