5 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Leksell GammaPlan 8.0 image fusion Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health professions (Neurosurgeons, Radiation therapists, Radiation Physicists) such that the desired radiation does is proved by the Leksell Gamma Knife to a precisely defined target area within the cranium.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·January 7, 2008
Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·October 23, 2008
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
FDA Enforcement
Class II
·Terminated·Elekta Instrument AB·July 8, 2020
Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·September 17, 2010
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
FDA Recall
Terminated
·Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden·Product code HAW·June 10, 2020