Device Classification Name |
Radiological Computer-Assisted Prioritization Software For Lesions
|
510(k) Number |
K222076 |
Device Name |
EFAI ChestSuite XR Pleural Effusion Assessment System |
Applicant |
Ever Fortune.AI Co., Ltd. |
RM. D, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST DIST. |
Taichung City,
TW
403020
|
|
Applicant Contact |
Joseph Chang |
Correspondent |
Ever Fortune.AI Co., Ltd. |
RM. D, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST DIST. |
Taichung City,
TW
403020
|
|
Correspondent Contact |
Ti-Hao Wang |
Regulation Number | 892.2080
|
Classification Product Code |
|
Date Received | 07/14/2022 |
Decision Date | 09/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|