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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 K972686
Device Name VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
Applicant
Smv America
8380 Darrow Rd.
Twinsburg,  OH  44087
Applicant Contact WILLIAM BISHOP
Correspondent
Smv America
8380 Darrow Rd.
Twinsburg,  OH  44087
Correspondent Contact WILLIAM BISHOP
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/17/1997
Decision Date 10/14/1997
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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