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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K113449
Device Name FUSION FLAT PANEL
Applicant
ICRCO INC.
2580 WEST 237TH STREET
TORRANCE,  CA  90505
Applicant Contact GREG WACHTLER
Correspondent
ICRCO INC.
2580 WEST 237TH STREET
TORRANCE,  CA  90505
Correspondent Contact GREG WACHTLER
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/21/2011
Decision Date 06/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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