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iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

FDA Enforcement
Class II ·Terminated·Iba Dosimetry Gmbh·December 18, 2013

COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

FDA Enforcement
Class II ·Terminated·Iba Dosimetry Gmbh·March 4, 2015

IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2

FDA Enforcement
Class II ·Terminated·Iba Dosimetry Gmbh·January 27, 2016

COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

FDA Enforcement
Class II ·Terminated·Iba Dosimetry Gmbh·November 12, 2014

myQA iON; Article Number: MQ10-000;

FDA Enforcement
Class II ·Ongoing·IBA Dosimetry GmbH·May 7, 2025

TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18

FDA Enforcement
Class II ·Ongoing·Tomtec Imaging Systems Gmbh·July 15, 2020