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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 K013897
Device Name SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
Applicant
Bio-Scan S.A
153 Sanford Ln.
Stamford,  CT  06905
Applicant Contact RICHARD M SANO
Correspondent
Bio-Scan S.A
153 Sanford Ln.
Stamford,  CT  06905
Correspondent Contact RICHARD M SANO
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LNH  
Date Received11/23/2001
Decision Date 05/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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