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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K980213
Device Name DI-2000
Applicant
Lumisys, Inc.
1350 N. Kolb Rd.
Tucson,  AZ  85715
Applicant Contact TRINDY LEFORGE
Correspondent
Lumisys, Inc.
1350 N. Kolb Rd.
Tucson,  AZ  85715
Correspondent Contact TRINDY LEFORGE
Regulation Number892.2030
Classification Product Code
LMA  
Date Received01/09/1998
Decision Date 03/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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