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FDA 510(k) Application Details - K182665
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K182665
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
Sensus Healthcare, Inc.
851 Broken Sound Parkway NW
Suite 215
Boca Raton, FL 33487 US
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Contact
Nicolas Soro
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2018
Decision Date
02/21/2019
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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