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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0648-2016

RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

Publicado el 20 de enero de 2016 · Inicio del retiro: 5 de noviembre de 2015

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Brainlab AG
Distribuidor
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
Lote
Adaptive Hybrid Surgery Analysis version 1.0.0 Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE 21703-02 ELEMENTS ADAPT HYB SURG ANALYSIS INST 21702 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-12 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-36 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-60 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21703 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-12 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-36 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-60 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21713 ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS 21722 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-12 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-36 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-60 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21723 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-12 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-36 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-60 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21732 ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M
Clasificación de riesgo
Class II
Área (FDA)
device
País
Germany

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