Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K231690 |
Device Name |
iCAS-LV |
Applicant |
HighRAD Ltd. |
132 Menachem Begin Rd. Azrieli Center, Round Tower Fl.22 |
Tel Aviv,
IL
6702101
|
|
Applicant Contact |
Yossi Srour |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth St. |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith, M.D., J.D. |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/09/2023 |
Decision Date | 03/01/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|