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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K252258
Device Name VERIQA RT EPID 3D
Applicant
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Loerracher Strasse 7
Freiburg,  DE 79115
Applicant Contact Ats Sandor-Csaba
Correspondent
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Loerracher Strasse 7
Freiburg,  DE 79115
Correspondent Contact Ats Sandor-Csaba
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/21/2025
Decision Date 04/15/2026
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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