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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 K010137
Device Name ORBITER II CCI/SPECT ORBITER II CCI/SPECT
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact RONALD NOLTE
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 NORTH BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact RONALD NOLTE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/17/2001
Decision Date 02/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
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