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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K000770
Device Name PROVIEW MEDICAL IMAGE DISPLAY MODULE
Applicant
Cerner Corp.
2800 Rockcreek Pkwy.
Kansas City,  MO  64117
Applicant Contact SHELLEY LOOBY
Correspondent
Cerner Corp.
2800 Rockcreek Pkwy.
Kansas City,  MO  64117
Correspondent Contact SHELLEY LOOBY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/09/2000
Decision Date 05/16/2000
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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