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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K190839
Device Name GammaTile
Applicant
Gt Medical Technologies
1809 S. Holbrook Ln.
Suite 107
Tempe,  AZ  85281
Applicant Contact Jessica Newhard
Correspondent
Gt Medical Technologies
1809 S. Holbrook Ln.
Suite 107
Tempe,  AZ  85281
Correspondent Contact Jessica Newhard
Regulation Number892.5730
Classification Product Code
KXK  
Date Received04/01/2019
Decision Date 01/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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