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FDA 510(k) Application Details - K180015
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K180015
Device Name
System, X-Ray, Tomography, Computed
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou 215024 CN
Other 510(k) Applications for this Company
Contact
Gordon Shu
Other 510(k) Applications for this Contact
Regulation Number
892.1750
More FDA Info for this Regulation Number
Classification Product Code
JAK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/02/2018
Decision Date
03/20/2018
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
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