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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K072867
Device Name IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
Applicant
Imix Adr Finland OY
75 Orchard Spring Ests
Waterbury,  VT  05676
Applicant Contact JAMES TAYLOR
Correspondent
Imix Adr Finland OY
75 Orchard Spring Ests
Waterbury,  VT  05676
Correspondent Contact JAMES TAYLOR
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/05/2007
Decision Date 11/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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