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July 24, 2019
Company: Elekta, Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network...
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