Device Classification Name |
Radiological Computer-Assisted Triage And Notification Software
|
510(k) Number |
K182875 |
Device Name |
DeepCT |
Applicant |
Deep01 Limited |
Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. |
Taipei City,
TW
10091
|
|
Applicant Contact |
William Lai |
Correspondent |
Deep01 Limited |
Rm. 5, 11F., No.162, Sec. 4, Roosevelt Rd. |
Taipei City,
TW
10091
|
|
Correspondent Contact |
William Lai |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 10/12/2018 |
Decision Date | 07/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|