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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 K082386
FOIA Releasable 510(k) K082386
Device Name INREACH PLANNING LAPTOP
Applicant
Superdimension, Ltd.
161 Cheshire Ln. N, Suite 100
Plymouth,  MN  55441
Applicant Contact MARGARET DEPUYDT
Correspondent
Superdimension, Ltd.
161 Cheshire Ln. N, Suite 100
Plymouth,  MN  55441
Correspondent Contact MARGARET DEPUYDT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/19/2008
Decision Date 09/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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