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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 K223639
Device Name VisAble.IO
Applicant
Techsomed
Meir Weisgal 2
Rehovot,  IL 7654055
Applicant Contact Dalia Dickman, PhD
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number892.2050
Classification Product Code
QTZ  
Subsequent Product Codes
LLZ   QIH  
Date Received12/05/2022
Decision Date 08/28/2023
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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