Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K222320 |
Device Name |
MedDream |
Applicant |
Softneta UAB |
K.Barsausko str. 59 |
Kaunas,
LT
51423
|
|
Applicant Contact |
Laura Baroniene |
Correspondent |
Licensale Inc |
3422 Leonardo Lane |
New Smyrna Beach,
FL
32168
|
|
Correspondent Contact |
Raymond Kelly |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/02/2022 |
Decision Date | 12/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|