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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K170909
Device Name Infinix INFX-8000V, V6.40
Toshiba Medical Systems Coroporation
1385 Shimoishigami
Otawara-Shi,  JP 324-8550
Applicant Contact Paul Biggins
Toshiba America Medical Systems, Inc.
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Paul Biggins
Regulation Number892.1650
Classification Product Code
Subsequent Product Codes
Date Received03/28/2017
Decision Date 06/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls