PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Image management software is a health product that can be registered with Anvisa and falls under the same equipment risk class, according to the provisions of Resolution RDC 185/2001 and Technical Note 04/2012 / GQUIP / GGTPS / ANVISA . The products described in this alert are free softwares, available in the public domain, used for the visualization and management of results of exams and diagnoses (DICOM files) obtained in procedures of radiography, tomography, magnetic resonance, among others. Since they have not been evaluated by the Agency in the pre-marketing stage, there is no guarantee as to the safety and efficacy of these products. In addition, there is no information available on representatives / distributors / technical assistance related to products in Brazil, which is an additional risk factor for their use. To consult the Technical Note n ° 04/2012 / GQUIP / GGTPS / ANVISA go to: http://portal.anvisa.gov.br/wps/wcm/connect/f96009004a70f3abb6f1f64600696f00/Note+T%C3%A9cnica+04_2012_GQUIP+Software+ MODULE = AJPERES #### Update of Field Action on 05/01/2018, currently the product PACS IMAGE MANAGEMENT SYSTEMS WITHOUT REGISTRATION AT ANVISA: OsiriX, KPACS, DICOM4Chee and eFilm release 1.5 Is duly registered with Anvisa.