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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 K240773
Device Name VisAble.IO
Applicant
Techsomed
Meir Weisgal 2
Rehovot,  IL 7654055
Applicant Contact Dalia Dickman
Correspondent
Techsomed
Meir Weisgal 2
Rehovot,  IL 7654055
Correspondent Contact Dalia Dickman
Regulation Number892.2050
Classification Product Code
QTZ  
Subsequent Product Codes
LLZ   QIH  
Date Received03/21/2024
Decision Date 04/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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