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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K002113
Device Name CTXA HIP; CTXA; QCT PRO CTXA HIP
Applicant
Mindways Software, Inc.
282 Second St., 4th Floor
San Francisco,  CA  94105
Applicant Contact CHRISTOPHER CANN
Correspondent
Mindways Software, Inc.
282 Second St., 4th Floor
San Francisco,  CA  94105
Correspondent Contact CHRISTOPHER CANN
Regulation Number892.1170
Classification Product Code
KGI  
Date Received06/07/2000
Decision Date 12/04/2001
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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