{"id":4139,"date":"2023-03-07T08:08:08","date_gmt":"2023-03-07T00:08:08","guid":{"rendered":"https:\/\/regask.com\/?p=4139"},"modified":"2024-10-15T00:55:10","modified_gmt":"2024-10-14T16:55:10","slug":"guia-de-diagnostico-por-rayos-x-de-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-diagnostic-x-ray-guidance\/","title":{"rendered":"La FDA de EE. UU. publica una gu\u00eda sobre \u201cGu\u00edas para ensambladores\u201d"},"content":{"rendered":"<div>\n<div>Este documento reemplaza la Gu\u00eda del ensamblador de equipos de rayos X de diagn\u00f3stico: responsabilidades de los ensambladores, distribuidores y comerciantes de equipos de rayos X de diagn\u00f3stico seg\u00fan el est\u00e1ndar de desempe\u00f1o federal (Publicaci\u00f3n DHHS FDA 81-8144, noviembre de 1980).<\/div>\n<div><\/div>\n<div>Proporciona recomendaciones sobre las responsabilidades generales de los fabricantes y ensambladores de equipos de rayos X de diagn\u00f3stico y la pol\u00edtica sobre el ensamblaje de equipos de rayos X de diagn\u00f3stico certificados.<\/div>\n<div><\/div>\n<div>Los fabricantes y ensambladores de equipos de rayos X de diagn\u00f3stico deben considerar estas recomendaciones, ya que representan el pensamiento actual de la FDA sobre el tema.<\/div>\n<\/div>\n<div><\/div>\n<div>\u00bfNecesita saber m\u00e1s sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos? <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-x-ray-equipment\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-319170967\">\n\n\t<div id=\"col-678886915\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Este documento reemplaza la Gu\u00eda del ensamblador de equipos de rayos X de diagn\u00f3stico: responsabilidades de los ensambladores, distribuidores y comerciantes de equipos de rayos X de diagn\u00f3stico seg\u00fan la norma federal de rendimiento (Publicaci\u00f3n DHHS FDA 81-8144, noviembre de 1980). Proporciona recomendaciones sobre las responsabilidades generales de los fabricantes y ensambladores de equipos de rayos X de diagn\u00f3stico y la pol\u00edtica sobre el ensamblaje de equipos de rayos X de diagn\u00f3stico certificados\u2026<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Diagnostic X-Ray Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. Stay compliant with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/guia-de-diagnostico-por-rayos-x-de-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Issues Guidance of &quot;Assembler&#039;s Guide to Diagnostic X-Ray Equipment&quot;\" \/>\n<meta property=\"og:description\" content=\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/guia-de-diagnostico-por-rayos-x-de-la-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-03-07T00:08:08+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-14T16:55:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Issues Guidance of &#8220;Assembler&#8217;s Guid&hellip;\",\"datePublished\":\"2023-03-07T00:08:08+00:00\",\"dateModified\":\"2024-10-14T16:55:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\"},\"wordCount\":172,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\",\"name\":\"FDA Diagnostic X-Ray Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-03-07T00:08:08+00:00\",\"dateModified\":\"2024-10-14T16:55:10+00:00\",\"description\":\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. 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