Device Classification Name |
Radiological Computer-Assisted Prioritization Software For Lesions
|
510(k) Number |
K230020 |
Device Name |
BriefCase |
Applicant |
Aidoc Medical, Ltd. |
3 Aminadav St. |
Tel-Aviv,
IL
6706703
|
|
Applicant Contact |
Amalia Schreier |
Correspondent |
Hogan Lovells U.S. LLP |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J Smith |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 01/03/2023 |
Decision Date | 02/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|