Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K240680 |
Device Name |
CDM Insights |
Applicant |
Oxford Brain Diagnostics Ltd |
Oxford Centre for Innovation, New Road |
Oxford,
GB
OX1 1BY
|
|
Applicant Contact |
Terry Pollard |
Correspondent |
Ken Blocking Consulting LLC |
3400 N Central Expy |
Suite #110-225 |
Richardson,
TX
75080
|
|
Correspondent Contact |
Yulia Nikova |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/11/2024 |
Decision Date | 12/06/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|