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FDA 510(k) Application Details - K220961
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K220961
Device Name
System, X-Ray, Tomography, Computed
Applicant
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka
Hino 191-8503 JP
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Contact
Wang Xing
Other 510(k) Applications for this Contact
Regulation Number
892.1750
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Classification Product Code
JAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2022
Decision Date
07/29/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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