Device Classification Name |
Radiological Image Processing Software For Radiation Therapy
|
510(k) Number |
K231765 |
Device Name |
Contour ProtégéAI |
Applicant |
MIM Software Inc. |
25800 Science Park Drive |
Suite 180 |
Cleveland,
OH
44122
|
|
Applicant Contact |
Lynn Hanigan |
Correspondent |
MIM Software Inc. |
25800 Science Park Drive |
Suite 180 |
Cleveland,
OH
44122
|
|
Correspondent Contact |
Lynn Hanigan |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/16/2023 |
Decision Date | 11/08/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|