Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K223322 |
Device Name |
Argus Cognitive ReVISION Software |
Applicant |
Argus Cognitive, Inc. |
Dartmouth Regional Technical Center |
16 Cavendish Court |
Lebanon,
NH
03766
|
|
Applicant Contact |
Attila Meretei |
Correspondent |
Argus Cognitive, Inc. |
Dartmouth Regional Technical Center |
16 Cavendish Court |
Lebanon,
NH
03766
|
|
Correspondent Contact |
Andrea Marosan |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/31/2022 |
Decision Date | 07/24/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|