{"id":8423,"date":"2025-08-26T14:52:55","date_gmt":"2025-08-26T05:52:55","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=8423"},"modified":"2026-01-12T15:40:57","modified_gmt":"2026-01-12T06:40:57","slug":"promo-achieves-fda-510k-clearance","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/es\/promo-achieves-fda-510k-clearance\/","title":{"rendered":"El sistema m\u00f3vil de rayos X PROMO de DRGEM obtiene la autorizaci\u00f3n 510(k) de la FDA de EE.UU."},"content":{"rendered":"<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">DRGEM ha anunciado que su sistema m\u00f3vil de rayos X PROMO ha recibido la tradicional autorizaci\u00f3n 510(k) de la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA). Este hito confirma que PROMO cumple todos los requisitos normativos para entrar en el mercado estadounidense, lo que refuerza la posici\u00f3n de DRGEM como l\u00edder mundial en diagn\u00f3stico por imagen.<\/mark><\/p>\n\n\n\n<figure class=\"wp-block-gallery aligncenter has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1080\" height=\"648\" data-id=\"8439\" src=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_2.jpg\" alt=\"\" class=\"wp-image-8439\" srcset=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_2.jpg 1080w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_2-300x180.jpg 300w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_2-1024x614.jpg 1024w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_2-768x461.jpg 768w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_2-18x12.jpg 18w\" sizes=\"(max-width: 1080px) 100vw, 1080px\" \/><\/figure>\n<\/figure>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-a-mobile-x-ray-designed-for-efficiency-and-flexibility\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">Una radiograf\u00eda m\u00f3vil dise\u00f1ada para la eficacia y la flexibilidad<\/mark><\/h4>\n\n\n\n<p>PROMO se ha desarrollado pensando en la eficiencia cl\u00ednica y las necesidades hospitalarias. El dise\u00f1o ligero del sistema garantiza una maniobrabilidad fluida en espacios reducidos como unidades de cuidados intensivos, quir\u00f3fanos y servicios de urgencias. Al mismo tiempo, su amplia cobertura de imagen permite un uso vers\u00e1til, desde radiograf\u00edas rutinarias de t\u00f3rax hasta ex\u00e1menes especializados a pie de cama.<\/p>\n\n\n\n<p>Las principales ventajas de PROMO son:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Compacto y m\u00f3vil<\/strong> - La estructura ligera con conducci\u00f3n de empujar hacia abajo y avanzar garantiza una maniobrabilidad suave incluso en espacios reducidos de hospitales.<strong><br><\/strong><\/li>\n\n\n\n<li><strong>Flexibilidad de posicionamiento<\/strong> - La columna giratoria de 180\u00b0, el cabezal de tubo flexible y la gran altura del punto focal proporcionan im\u00e1genes precisas para diversas necesidades cl\u00ednicas.<br><\/li>\n\n\n\n<li><strong>Im\u00e1genes de alta calidad con eficiencia<\/strong> - El generador de condensadores de 40 kW y el software RADMAX ofrecen im\u00e1genes n\u00edtidas y fiables, al tiempo que permiten un flujo de trabajo \u00e1gil y puntual.<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>J.B. Park, Presidente de DRGEM Corporation, coment\u00f3 la autorizaci\u00f3n:<\/p>\n\n\n\n<p><em>\"La obtenci\u00f3n de la autorizaci\u00f3n 510(k) de la FDA para PROMO supone un importante paso adelante en nuestra misi\u00f3n de ofrecer soluciones de imagen de primera clase. PROMO se desarroll\u00f3 para satisfacer las necesidades de los m\u00e9dicos que precisan im\u00e1genes oportunas, flexibles y fiables en el punto de atenci\u00f3n. Al combinar movilidad, eficiencia y asequibilidad, PROMO est\u00e1 listo para mejorar el diagn\u00f3stico por imagen a pie de cama en Estados Unidos y otros pa\u00edses. Esta autorizaci\u00f3n demuestra nuestra dedicaci\u00f3n a la calidad, la innovaci\u00f3n y la ampliaci\u00f3n del acceso a la imagen m\u00e9dica avanzada.<\/em><\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-strengthening-drgem-s-global-strategy\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">Reforzar la estrategia global de DRGEM<\/mark><\/h4>\n\n\n\n<p>La autorizaci\u00f3n de la FDA no es s\u00f3lo un hito normativo, sino tambi\u00e9n un avance estrat\u00e9gico para la visi\u00f3n a largo plazo de DRGEM. Al cumplir las estrictas normas reglamentarias estadounidenses, PROMO demuestra la capacidad de DRGEM para competir en los mercados de imagen m\u00e9dica m\u00e1s avanzados. Su equilibrio entre alto rendimiento y rentabilidad lo posiciona como una soluci\u00f3n ideal para hospitales y cl\u00ednicas que buscan mejorar la eficiencia diagn\u00f3stica sin comprometer la calidad.<\/p>\n\n\n\n<p class=\"translation-block\">A medida que DRGEM contin\u00faa su expansi\u00f3n mundial, PROMO refuerza su cartera de sistemas avanzados de diagn\u00f3stico en los que ya conf\u00edan m\u00e1s de 120 pa\u00edses. Este hito reafirma el compromiso de DRGEM de ofrecer soluciones completas de diagn\u00f3stico por imagen que capaciten a los profesionales de la imagen m\u00e9dica y mejoren los resultados de los pacientes.<\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>\ud83d\udc49 M\u00e1s informaci\u00f3n sobre PROMO: <a href=\"http:\/\/www.drgemhealthcare.com\/es\/products\/promo\/\">http:\/\/www.drgemhealthcare.com\/products\/promo<\/a><\/p>\n\n\n\n<p>\u3000<\/p>","protected":false},"excerpt":{"rendered":"<p>DRGEM announced that its PROMO Mobile X-ray System has received Traditional 510(k) Clearance from the U.S. Food and Drug Administration (FDA). This milestone confirms that PROMO meets all regulatory requirements for entry into the U.S. market, strengthening DRGEM\u2019s position as a global leader in diagnostic imaging. \u3000 A Mobile X-ray Designed for Efficiency and Flexibility [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":8436,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14,15],"tags":[104,105,108,26,103,101,111,106,109,110,99,107,100,102],"class_list":["post-8423","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news","category-product-updates","tag-bedside-x-ray","tag-cost-effective-imaging","tag-diagnostic-imaging","tag-drgem","tag-emergency-department-imaging","tag-fda-510k-clearance","tag-global-medical-imaging","tag-high-performance-x-ray","tag-icu-imaging","tag-medical-imaging","tag-mobile-x-ray","tag-or-imaging","tag-promo","tag-radiography-system"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DRGEM\u2019s PROMO Mobile X-ray System Achieves U.S. FDA 510(k) Clearance - DRGEM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.drgemhealthcare.com\/es\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DRGEM\u2019s PROMO Mobile X-ray System Achieves U.S. FDA 510(k) Clearance\" \/>\n<meta property=\"og:description\" content=\"DRGEM announced that its PROMO Mobile X-ray System has received Traditional 510(k) Clearance from the U.S. Food and Drug Administration (FDA). This milestone confirms that PROMO meets all regulatory requirements for entry into the U.S. market, strengthening DRGEM\u2019s position as a global leader in diagnostic imaging. \u3000 A Mobile X-ray Designed for Efficiency and Flexibility [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.drgemhealthcare.com\/es\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:site_name\" content=\"DRGEM\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/drgemglobal\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-26T05:52:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-01-12T06:40:57+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_3.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"mhpark\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@drgemhealthcare\" \/>\n<meta name=\"twitter:site\" content=\"@drgemhealthcare\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"mhpark\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.drgemhealthcare.com\/promo-achieves-fda-510k-clearance\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/promo-achieves-fda-510k-clearance\/\"},\"author\":{\"name\":\"mhpark\",\"@id\":\"https:\/\/www.drgemhealthcare.com\/#\/schema\/person\/8132f0407a7baab8d37fb3b9b7d1653f\"},\"headline\":\"DRGEM\u2019s PROMO Mobile X-ray System Achieves U.S. FDA 510(k) Clearance\",\"datePublished\":\"2025-08-26T05:52:55+00:00\",\"dateModified\":\"2026-01-12T06:40:57+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/promo-achieves-fda-510k-clearance\/\"},\"wordCount\":392,\"publisher\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.drgemhealthcare.com\/promo-achieves-fda-510k-clearance\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2025\/08\/Newsletter_2508_img_3.jpg\",\"keywords\":[\"Bedside X-ray\",\"Cost-Effective Imaging\",\"Diagnostic Imaging\",\"DRGEM\",\"Emergency Department Imaging\",\"FDA 510k clearance\",\"Global Medical Imaging\",\"High-Performance X-ray\",\"ICU Imaging\",\"Medical Imaging\",\"Mobile X-ray\",\"OR Imaging\",\"PROMO\",\"Radiography System\"],\"articleSection\":[\"DRGEM News\",\"Product Updates\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.drgemhealthcare.com\/promo-achieves-fda-510k-clearance\/\",\"url\":\"https:\/\/www.drgemhealthcare.com\/promo-achieves-fda-510k-clearance\/\",\"name\":\"DRGEM\u2019s PROMO Mobile X-ray System Achieves U.S. FDA 510(k) Clearance - 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