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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
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