{"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\/fr\/promo-achieves-fda-510k-clearance\/","title":{"rendered":"Le syst\u00e8me mobile de radiologie PROMO de DRGEM obtient l'autorisation 510(k) de la FDA am\u00e9ricaine"},"content":{"rendered":"<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">DRGEM a annonc\u00e9 que son syst\u00e8me mobile de radiologie PROMO a re\u00e7u l'autorisation traditionnelle 510(k) de la Food and Drug Administration (FDA) des \u00c9tats-Unis. Cette \u00e9tape importante confirme que le PROMO r\u00e9pond \u00e0 toutes les exigences r\u00e9glementaires pour entrer sur le march\u00e9 am\u00e9ricain, renfor\u00e7ant ainsi la position de DRGEM en tant que leader mondial dans le domaine de l'imagerie diagnostique.<\/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\">Un rayon X mobile con\u00e7u pour l'efficacit\u00e9 et la flexibilit\u00e9<\/mark><\/h4>\n\n\n\n<p>Le PROMO a \u00e9t\u00e9 d\u00e9velopp\u00e9 en tenant compte de l'efficacit\u00e9 clinique et des besoins des h\u00f4pitaux. La l\u00e9g\u00e8ret\u00e9 du syst\u00e8me garantit une grande maniabilit\u00e9 dans les espaces confin\u00e9s tels que les unit\u00e9s de soins intensifs, les salles d'op\u00e9ration et les services d'urgence. En m\u00eame temps, sa large couverture d'imagerie permet une utilisation polyvalente, de la radiographie thoracique de routine aux examens sp\u00e9cialis\u00e9s au chevet du patient.<\/p>\n\n\n\n<p>Les principaux avantages de PROMO sont les suivants<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Compact et mobile<\/strong> - La structure l\u00e9g\u00e8re et la conduite push-down-and-go garantissent une man\u0153uvre en douceur, m\u00eame dans les espaces hospitaliers restreints.<strong><br><\/strong><\/li>\n\n\n\n<li><strong>Flexibilit\u00e9 de positionnement<\/strong> - La colonne rotative \u00e0 180\u00b0, la t\u00eate de tube flexible et la hauteur \u00e9lev\u00e9e de la tache focale permettent une imagerie pr\u00e9cise pour divers besoins cliniques.<br><\/li>\n\n\n\n<li><strong>Imagerie de haute qualit\u00e9 et efficacit\u00e9<\/strong> - Le g\u00e9n\u00e9rateur \u00e0 condensateur de 40 kW et le logiciel RADMAX fournissent des images nettes et fiables tout en permettant un flux de travail rapide et rationalis\u00e9.<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>Commentant cette autorisation, M. J.B. Park, pr\u00e9sident de DRGEM Corporation, a d\u00e9clar\u00e9 :<\/p>\n\n\n\n<p><em>\"L'obtention de l'autorisation 510(k) de la FDA pour le PROMO marque une \u00e9tape importante dans notre mission de fournir des solutions d'imagerie de classe mondiale. Le PROMO a \u00e9t\u00e9 d\u00e9velopp\u00e9 pour r\u00e9pondre aux besoins des cliniciens qui exigent une imagerie rapide, flexible et fiable sur le lieu de soins. En combinant mobilit\u00e9, efficacit\u00e9 et prix abordable, le PROMO est pr\u00eat \u00e0 am\u00e9liorer l'imagerie au chevet des patients aux \u00c9tats-Unis et ailleurs. Cette autorisation t\u00e9moigne de notre engagement en faveur de la qualit\u00e9, de l'innovation et de l'\u00e9largissement de l'acc\u00e8s \u00e0 l'imagerie m\u00e9dicale avanc\u00e9e.<\/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\">Renforcer la strat\u00e9gie mondiale de DRGEM<\/mark><\/h4>\n\n\n\n<p>L'autorisation de la FDA n'est pas seulement une \u00e9tape r\u00e9glementaire, mais aussi une avanc\u00e9e strat\u00e9gique pour la vision \u00e0 long terme de DRGEM. En r\u00e9pondant aux normes r\u00e9glementaires am\u00e9ricaines strictes, le PROMO d\u00e9montre la capacit\u00e9 de DRGEM \u00e0 \u00eatre comp\u00e9titif sur les march\u00e9s les plus avanc\u00e9s de l'imagerie m\u00e9dicale. Son \u00e9quilibre entre haute performance et rentabilit\u00e9 en fait une solution id\u00e9ale pour les h\u00f4pitaux et les cliniques qui cherchent \u00e0 am\u00e9liorer l'efficacit\u00e9 de leurs diagnostics sans compromettre la qualit\u00e9.<\/p>\n\n\n\n<p class=\"translation-block\">Alors que DRGEM poursuit son expansion \u00e0 l'\u00e9chelle mondiale, PROMO renforce son portefeuille de syst\u00e8mes de diagnostic avanc\u00e9s qui font d\u00e9sormais l'objet d'une grande confiance dans plus de 120 pays. Cette \u00e9tape importante r\u00e9affirme l'engagement de DRGEM \u00e0 fournir des solutions d'imagerie compl\u00e8tes qui permettent aux professionnels de l'imagerie m\u00e9dicale d'agir et d'am\u00e9liorer les r\u00e9sultats pour les patients.<\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>\ud83d\udc49 En savoir plus sur PROMO : <a href=\"http:\/\/www.drgemhealthcare.com\/fr\/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\/fr\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/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=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"mhpark\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\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\":\"fr-FR\"},{\"@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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