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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 K191267
Device Name ImagingRing System on Rails
Applicant
MedPhoton GmbH
Strubergasse 16
Salzburg,  AT 5020
Applicant Contact Daniel Schaffarzick
Correspondent
MedPhoton GmbH
Strubergasse 16
Salzburg,  AT 5020
Correspondent Contact Daniel Schaffarzick
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/10/2019
Decision Date 08/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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