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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K954071
Device Name IDXVIEW
Applicant
Idx Systems Corp.
1400 Shelburne Rd.
P.O. Box 1070
Burlington,  VT  05402 -1070
Applicant Contact TANIA HORTON
Correspondent
Idx Systems Corp.
1400 Shelburne Rd.
P.O. Box 1070
Burlington,  VT  05402 -1070
Correspondent Contact TANIA HORTON
Regulation Number892.2020
Classification Product Code
LMD  
Date Received08/30/1995
Decision Date 02/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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