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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K182076
Device Name Elekta Unity
Elekta Limited
Fleming Way
Crawley,  GB RH10 9RR
Applicant Contact Nicholas Power
Elekta Limited
Fleming Way
Crawley,  GB RH10 9RR
Correspondent Contact Nicholas Power
Regulation Number892.5050
Classification Product Code
Date Received08/01/2018
Decision Date 12/04/2018
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