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FDA 510(k) Application Details - K151280
Device Classification Name
More FDA Info for this Device
510(K) Number
K151280
Device Name
MultiScan G-Arm System
Applicant
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD.
B2-2 NEW CITY INDUSTRIAL PARK, NO. 9 KECHUANG 2ND ST.,
YIZHUANG
BEIJING 100023 CN
Other 510(k) Applications for this Company
Contact
June Li
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2015
Decision Date
09/30/2015
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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