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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 K982387
Device Name E.CAM EXTRA HIGH ENERGY COLLIMATOR
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact ANDREA DISANTI
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact ANDREA DISANTI
Regulation Number892.1200
Classification Product Code
KPS  
Date Received07/09/1998
Decision Date 10/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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