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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Fraxion
Classification Name: ACCELERATOR, LINEAR, MEDICAL
Product Code: IYE
Device Class: 2
Regulation Number: 892.5050
Medical Specialty: Radiology
Registered Establishment Name: 3C-Medical Intelligence GmbH
Registered Establishment Number: 9710332
Premarket Submission Number: K112210
Owner/Operator: 3C-Medical Intelligence GmbH
Owner/Operator Number: 10082856
Establishment Operations: Manufacturer
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