Device Classification Name |
Radiological Computer-Assisted Triage And Notification Software
|
510(k) Number |
K180647 |
Device Name |
BriefCase |
Applicant |
Aidoc Medical, Ltd. |
Yigal Alon 92 |
Tel-Aviv,
IL
6789138
|
|
Applicant Contact |
Nimrod Epstein |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth St. NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 03/12/2018 |
Decision Date | 08/01/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|