{"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\/tr\/promo-achieves-fda-510k-clearance\/","title":{"rendered":"DRGEM'nin PROMO Mobil X-ray Sistemi ABD FDA 510(k) \u0130znini Ald\u0131"},"content":{"rendered":"<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">DRGEM, PROMO Mobil X-ray Sisteminin ABD G\u0131da ve \u0130la\u00e7 Dairesi'nden (FDA) Geleneksel 510(k) \u0130zni ald\u0131\u011f\u0131n\u0131 duyurdu. Bu d\u00f6n\u00fcm noktas\u0131, PROMO'nin ABD pazar\u0131na giri\u015f i\u00e7in t\u00fcm yasal gereklilikleri kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 teyit ederek DRGEM'nin tan\u0131sal g\u00f6r\u00fcnt\u00fclemede k\u00fcresel bir lider olarak konumunu g\u00fc\u00e7lendiriyor.<\/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\">Verimlilik ve Esneklik i\u00e7in Tasarlanm\u0131\u015f Bir Mobil X-ray<\/mark><\/h4>\n\n\n\n<p>PROMO, klinik verimlilik ve hastane ihtiya\u00e7lar\u0131 g\u00f6z \u00f6n\u00fcnde bulundurularak geli\u015ftirilmi\u015ftir. Sistemin hafif tasar\u0131m\u0131, yo\u011fun bak\u0131m \u00fcniteleri, ameliyathaneler ve acil servisler gibi dar alanlarda sorunsuz manevra kabiliyeti sa\u011flar. Ayn\u0131 zamanda geni\u015f g\u00f6r\u00fcnt\u00fcleme kapsam\u0131, rutin g\u00f6\u011f\u00fcs radyografisinden \u00f6zel hasta ba\u015f\u0131 muayenelerine kadar \u00e7ok y\u00f6nl\u00fc kullan\u0131m\u0131 destekler.<\/p>\n\n\n\n<p>PROMO'nin temel faydalar\u0131 \u015funlard\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Kompakt ve Mobil<\/strong> - Bas-indir s\u00fcr\u00fc\u015fl\u00fc hafif yap\u0131, dar hastane alanlar\u0131nda bile sorunsuz manevra kabiliyeti sa\u011flar.<strong><br><\/strong><\/li>\n\n\n\n<li><strong>Konumland\u0131rma Esnekli\u011fi<\/strong> - 180\u00b0 d\u00f6nen kolon, esnek t\u00fcp ba\u015fl\u0131\u011f\u0131 ve y\u00fcksek odak noktas\u0131 y\u00fcksekli\u011fi, farkl\u0131 klinik ihtiya\u00e7lar i\u00e7in do\u011fru g\u00f6r\u00fcnt\u00fcleme sa\u011flar.<br><\/li>\n\n\n\n<li><strong>Verimlilik ile Y\u00fcksek Kaliteli G\u00f6r\u00fcnt\u00fcleme<\/strong> - 40 kW kapasit\u00f6r jenerat\u00f6r\u00fc ve RADMAX yaz\u0131l\u0131m\u0131 keskin, g\u00fcvenilir g\u00f6r\u00fcnt\u00fcler sunarken zaman\u0131nda ve kolayla\u015ft\u0131r\u0131lm\u0131\u015f bir i\u015f ak\u0131\u015f\u0131n\u0131 da destekler.<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>DRGEM Corporation Ba\u015fkan\u0131 Bay J.B. Park, izinle ilgili olarak \u015funlar\u0131 s\u00f6yledi:<\/p>\n\n\n\n<p><em>\"PROMO i\u00e7in FDA 510(k) izninin al\u0131nmas\u0131, birinci s\u0131n\u0131f g\u00f6r\u00fcnt\u00fcleme \u00e7\u00f6z\u00fcmleri sunma misyonumuzda \u00f6nemli bir ad\u0131md\u0131r. PROMO, bak\u0131m noktas\u0131nda zaman\u0131nda, esnek ve g\u00fcvenilir g\u00f6r\u00fcnt\u00fclemeye ihtiya\u00e7 duyan klinisyenlerin ihtiya\u00e7lar\u0131n\u0131 kar\u015f\u0131lamak i\u00e7in geli\u015ftirildi. Mobilite, verimlilik ve ekonomikli\u011fi bir araya getiren PROMO, ABD ve \u00f6tesinde hasta ba\u015f\u0131 g\u00f6r\u00fcnt\u00fclemeyi iyile\u015ftirmeye haz\u0131r. Bu onay, kalite, yenilik ve geli\u015fmi\u015f t\u0131bbi g\u00f6r\u00fcnt\u00fclemeye eri\u015fimi geni\u015fletmeye olan ba\u011fl\u0131l\u0131\u011f\u0131m\u0131z\u0131 g\u00f6stermektedir<\/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\">DRGEM'nin K\u00fcresel Stratejisinin G\u00fc\u00e7lendirilmesi<\/mark><\/h4>\n\n\n\n<p>FDA onay\u0131 sadece d\u00fczenleyici bir kilometre ta\u015f\u0131 de\u011fil, ayn\u0131 zamanda DRGEM'nin uzun vadeli vizyonu i\u00e7in stratejik bir ilerlemedir. S\u0131k\u0131 ABD d\u00fczenleme standartlar\u0131n\u0131 kar\u015f\u0131layan PROMO, DRGEM'nin en geli\u015fmi\u015f t\u0131bbi g\u00f6r\u00fcnt\u00fcleme pazarlar\u0131nda rekabet edebilme yetene\u011fini g\u00f6stermektedir. Y\u00fcksek performans ve maliyet etkinli\u011fi dengesi, kaliteden \u00f6d\u00fcn vermeden te\u015fhis verimlili\u011fini art\u0131rmak isteyen hastaneler ve klinikler i\u00e7in ideal bir \u00e7\u00f6z\u00fcm olarak konumland\u0131r\u0131yor.<\/p>\n\n\n\n<p class=\"translation-block\">DRGEM k\u00fcresel olarak geni\u015flemeye devam ederken, PROMO de 120'den fazla \u00fclkede g\u00fcvenilen geli\u015fmi\u015f tan\u0131 sistemleri portf\u00f6y\u00fcn\u00fc g\u00fc\u00e7lendiriyor. Bu kilometre ta\u015f\u0131, DRGEM'nin t\u0131bbi g\u00f6r\u00fcnt\u00fcleme uzmanlar\u0131n\u0131 g\u00fc\u00e7lendiren ve hasta sonu\u00e7lar\u0131n\u0131 iyile\u015ftiren eksiksiz g\u00f6r\u00fcnt\u00fcleme \u00e7\u00f6z\u00fcmleri sunma taahh\u00fcd\u00fcn\u00fc yeniden teyit ediyor<\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>\ud83d\udc49 PROMO hakk\u0131nda daha fazla bilgi edinin: <a href=\"http:\/\/www.drgemhealthcare.com\/tr\/urunler\/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\/tr\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\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\/tr\/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=\"Yazan:\" \/>\n\t<meta name=\"twitter:data1\" content=\"mhpark\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tahmini okuma s\u00fcresi\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 dakika\" \/>\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\":\"tr\"},{\"@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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