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FDA 510(k) Application Details - K124048
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K124048
Device Name
System, Image Processing, Radiological
Applicant
INTUITIVE IMAGING INFORMATICS, LLC
30 Hackamore Ln Ste 6
BELL CANYON, CA 91307 US
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Contact
CINDY SIMONI
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
12/31/2012
Decision Date
01/29/2013
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
Y
Expedited Review
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