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FDA 510(k) Application Details - K141343
Device Classification Name
System, Therapeutic, X-Ray
More FDA Info for this Device
510(K) Number
K141343
Device Name
System, Therapeutic, X-Ray
Applicant
ICAD, INC.
98 SPIT BROOK ROAD
SUITE 100
NASHUA, NH 03062 US
Other 510(k) Applications for this Company
Contact
John DeLucia
Other 510(k) Applications for this Contact
Regulation Number
892.5900
More FDA Info for this Regulation Number
Classification Product Code
JAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2014
Decision Date
09/05/2014
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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