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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 K192482
Device Name Elekta Unity
Applicant
Elekta Limited
Fleming Way
crawley,  GB rh10 9rr
Applicant Contact nicholas power
Correspondent
Elekta Limited
Fleming Way
crawley,  GB rh10 9rr
Correspondent Contact nicholas power
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/10/2019
Decision Date 12/05/2019
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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