6 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
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
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021