3 results
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12ms
·
Sources: EU EUDAMED, US FDA
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014