Device Classification Name |
Radiological Image Processing Software For Radiation Therapy
|
510(k) Number |
K231855 |
Device Name |
QOCA® image Smart RT Contouring System |
Applicant |
Quanta Computer Inc. |
No. 188, Wenhua 2nd Rd |
Guishan Dist. |
Taoyuan City,
TW
33383
|
|
Applicant Contact |
Joe Wang |
Correspondent |
Quanta Computer Inc. |
No. 188, Wenhua 2nd Rd |
Guishan Dist. |
Taoyuan City,
TW
33383
|
|
Correspondent Contact |
Joe Wang |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 06/23/2023 |
Decision Date | 02/13/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|