{"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\/id\/promo-achieves-fda-510k-clearance\/","title":{"rendered":"Sistem X-ray Seluler DRGEM dari PROMO Mencapai Izin FDA 510 (k) A.S."},"content":{"rendered":"<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">DRGEM mengumumkan bahwa Sistem X-ray Seluler PROMO telah menerima Izin 510 (k) Tradisional dari Badan Pengawas Obat dan Makanan AS (FDA). Pencapaian ini menegaskan bahwa PROMO memenuhi semua persyaratan peraturan untuk masuk ke pasar AS, memperkuat posisi DRGEM sebagai pemimpin global dalam pencitraan diagnostik.<\/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\">Sinar-X Bergerak yang Dirancang untuk Efisiensi dan Fleksibilitas<\/mark><\/h4>\n\n\n\n<p>PROMO dikembangkan dengan mempertimbangkan efisiensi klinis dan kebutuhan rumah sakit. Desain sistem yang ringan memastikan kemampuan manuver yang mulus di ruang terbatas seperti unit perawatan intensif, ruang operasi, dan unit gawat darurat. Pada saat yang sama, cakupan pencitraannya yang luas mendukung penggunaan serbaguna, mulai dari radiografi dada rutin hingga pemeriksaan di samping tempat tidur khusus.<\/p>\n\n\n\n<p>Manfaat utama dari PROMO meliputi:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ringkas &amp; Seluler<\/strong> - Struktur yang ringan dengan penggerak dorong-dan-pergi memastikan kemampuan manuver yang mulus bahkan di ruang rumah sakit yang sempit.<strong><br><\/strong><\/li>\n\n\n\n<li><strong>Fleksibilitas Pemosisian<\/strong> - Kolom berputar 180\u00b0, kepala tabung fleksibel, dan ketinggian titik fokus yang tinggi memberikan pencitraan yang akurat di berbagai kebutuhan klinis.<br><\/li>\n\n\n\n<li><strong>Pencitraan Berkualitas Tinggi dengan Efisiensi<\/strong> - Generator kapasitor 40 kW dan perangkat lunak RADMAX menghasilkan gambar yang tajam dan andal sekaligus mendukung alur kerja yang tepat waktu dan efisien.<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>Mengomentari izin tersebut, J.B. Park, Presiden DRGEM Corporation, menyatakan:<\/p>\n\n\n\n<p><em>\"Meraih izin FDA 510(k) untuk PROMO menandai langkah maju yang penting dalam misi kami untuk memberikan solusi pencitraan kelas dunia. PROMO dikembangkan untuk memenuhi kebutuhan para dokter yang memerlukan pencitraan yang tepat waktu, fleksibel, dan dapat diandalkan di tempat perawatan. Dengan menggabungkan mobilitas, efisiensi, dan keterjangkauan, PROMO siap untuk meningkatkan pencitraan di samping tempat tidur di A.S. dan sekitarnya. Izin ini menunjukkan dedikasi kami terhadap kualitas, inovasi, dan perluasan akses ke pencitraan medis tingkat lanjut<\/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\">Memperkuat Strategi Global DRGEM<\/mark><\/h4>\n\n\n\n<p>Izin FDA tidak hanya merupakan tonggak peraturan tetapi juga kemajuan strategis untuk visi jangka panjang DRGEM. Dengan memenuhi standar peraturan AS yang ketat, PROMO menunjukkan kemampuan DRGEM untuk bersaing di pasar pencitraan medis yang paling canggih. Keseimbangan antara kinerja tinggi dan efektivitas biaya memposisikannya sebagai solusi ideal untuk rumah sakit dan klinik yang ingin meningkatkan efisiensi diagnostik tanpa mengorbankan kualitas.<\/p>\n\n\n\n<p class=\"translation-block\">Seiring dengan terus berkembangnya DRGEM secara global, PROMO memperkuat portofolio sistem diagnostik canggihnya yang kini dipercaya di lebih dari 120 negara. Tonggak sejarah ini menegaskan kembali komitmen DRGEM untuk memberikan solusi pencitraan lengkap yang memberdayakan para profesional pencitraan medis dan meningkatkan hasil pasien<\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>\ud83d\udc49 Pelajari lebih lanjut tentang PROMO: <a href=\"http:\/\/www.drgemhealthcare.com\/id\/produk\/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\/id\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\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\/id\/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=\"Ditulis oleh\" \/>\n\t<meta name=\"twitter:data1\" content=\"mhpark\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimasi waktu membaca\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 menit\" \/>\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\":\"id\"},{\"@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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