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FDA 510(k) Application Details - K170719
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
More FDA Info for this Device
510(K) Number
K170719
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
Anzai Medical Co., Ltd.
3-9-15 Nishi-Shinagawa
Shinagawa-ku
Tokyo 141-0033 JP
Other 510(k) Applications for this Company
Contact
Naoya Iwasaki
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
LHN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2017
Decision Date
04/05/2017
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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