Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K220649 |
Device Name |
Elucis |
Applicant |
Realize Medical Inc. |
405-2197 Riverside Drive |
Ottawa,
CA
K1H 7X3
|
|
Applicant Contact |
Dan La Russa |
Correspondent |
Realize Medical Inc. |
405-2197 Riverside Drive |
Ottawa,
CA
K1H 7X3
|
|
Correspondent Contact |
Dan La Russa |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/07/2022 |
Decision Date | 01/17/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|