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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K082581
Device Name C-QUEST
Applicant
Medx, Inc.
220 River Rd.
Claremont,  NH  03743
Applicant Contact WILLIAM GREENROSE
Correspondent
Medx, Inc.
220 River Rd.
Claremont,  NH  03743
Correspondent Contact WILLIAM GREENROSE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/05/2008
Decision Date 11/14/2008
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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