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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 K252947
Device Name HistoSonics® Planning Tool
Applicant
HistoSonics, Inc.
16305 36th Ave. N.
Suite 300
Plymouth,  MN  55446
Applicant Contact LeeAnne Swiridow
Correspondent
HistoSonics, Inc.
16305 36th Ave. N.
Suite 300
Plymouth,  MN  55446
Correspondent Contact LeeAnne Swiridow
Regulation Number892.2050
Classification Product Code
QTZ  
Date Received09/15/2025
Decision Date 05/29/2026
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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