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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
510(k) Number K253264
Device Name myAblation Guide (VC10A)
Applicant
Siemens Healthcare GmbH
Henkestr. 127
Erlanger,  DE 91052
Applicant Contact Lynn Allman
Correspondent
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto,  CA  94304
Correspondent Contact Lynn Allman
Regulation Number892.2050
Classification Product Code
QTZ  
Date Received09/29/2025
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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