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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 K170490
Device Name Celesteion, PCA-9000A/3
Applicant
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Toshiba America Medical Systems, Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Orlando Tadeo
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received02/17/2017
Decision Date 06/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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