Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K162011 |
Device Name |
MedDream |
Applicant |
SOFTNETA UAB |
K.BARAUSKO STR. 59 |
KAUNAS,
LT
51423
|
|
Applicant Contact |
LAURA BARONIENE |
Correspondent |
LICENSALE INC |
57 LAZY BROOK RD |
MONROE,
CT
06468
|
|
Correspondent Contact |
RAYMOND KELLY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/21/2016 |
Decision Date | 10/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|