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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 K082450
Device Name IDR
Applicant
Icrco, Inc.
2580 W. 237th St.
Torrance,  CA  90505
Applicant Contact THOMAS CHANEY
Correspondent
Icrco, Inc.
2580 W. 237th St.
Torrance,  CA  90505
Correspondent Contact THOMAS CHANEY
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/25/2008
Decision Date 06/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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