Device Classification Name |
System, Tomography, Computed, Emission
More FDA Info for this Device |
510(K) Number |
K213731 |
Device Name |
System, Tomography, Computed, Emission |
Applicant |
Ever Fortune.AI Co., Ltd.
8F., No. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung City 403020 TW
Other 510(k) Applications for this Company
|
Contact |
Cheng Ming-Fong
Other 510(k) Applications for this Contact |
Regulation Number |
892.1200
More FDA Info for this Regulation Number |
Classification Product Code |
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/26/2021 |
Decision Date |
05/31/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|