Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K202546 |
Device Name |
LVivo Seamless |
Applicant |
DiA Imaging Analysis Ltd |
77 Haenergia Street |
Beer-Sheva,
IL
8470912
|
|
Applicant Contact |
Michal Yaacobi |
Correspondent |
Medicsense USA |
291 Hillside Avenue |
Somerset,
MA
02726
|
|
Correspondent Contact |
George Hattub |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/02/2020 |
Decision Date | 09/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|