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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K100352
Device Name DIAGNOSOFT HARP MODEL 2.06
Applicant
Diagnosoft, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact JEFFREY ROBERTS
Correspondent
Diagnosoft, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact JEFFREY ROBERTS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/12/2010
Decision Date 03/11/2010
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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