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FDA 510(k) Application Details - K042697
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K042697
Device Name
System, Image Processing, Radiological
Applicant
ICAD INC.
2689 COMMONS BLVD., SUITE 100
BEAVERCREEK, OH 45431 US
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Contact
JOHN ROSENSTENGEL
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2004
Decision Date
11/19/2004
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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