{"id":10667,"date":"2026-05-15T10:00:04","date_gmt":"2026-05-15T01:00:04","guid":{"rendered":"https:\/\/www.drgemhealthcare.com\/?p=10667"},"modified":"2026-05-15T10:00:39","modified_gmt":"2026-05-15T01:00:39","slug":"drgem-secures-u-s-fda-clearance-for-mobile-x-ray-system-raymo","status":"publish","type":"post","link":"https:\/\/www.drgemhealthcare.com\/id\/drgem-secures-u-s-fda-clearance-for-mobile-x-ray-system-raymo\/","title":{"rendered":"DRGEM Mendapat Persetujuan dari Badan Pengawas Obat dan Makanan AS (FDA) untuk Sistem Rontgen Portabel \u2018RAYMO\u2019"},"content":{"rendered":"<div class=\"wp-block-group is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-81d4e86f wp-block-group-is-layout-constrained\">\n<ul style=\"margin-top:20px;margin-bottom:20px\" class=\"wp-block-list\">\n<li style=\"margin-top:0px;margin-right:0px;margin-bottom:0px;margin-left:0px\">Memasuki pasar Amerika Utara secara penuh\u2026 Memenuhi persyaratan otorisasi penjualan AS<\/li>\n\n\n\n<li>Membuktikan daya saing sistem X-ray seluler generasi berikutnya berdasarkan fitur yang disesuaikan pengguna<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-image size-large\" style=\"margin-bottom:50px\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"687\" src=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/News_2605_RAYMO_FDA-1024x687.jpg\" alt=\"\" class=\"wp-image-10689\" srcset=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/News_2605_RAYMO_FDA-1024x687.jpg 1024w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/News_2605_RAYMO_FDA-300x201.jpg 300w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/News_2605_RAYMO_FDA-768x516.jpg 768w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/News_2605_RAYMO_FDA-18x12.jpg 18w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/News_2605_RAYMO_FDA.jpg 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p style=\"margin-bottom:30px\">DRGEM (CEO J. B. Park), sebuah perusahaan solusi pencitraan medis global, sedang mempercepat ekspansinya ke pasar Amerika Utara setelah memperoleh persetujuan dari Badan Pengawas Obat dan Makanan Amerika Serikat (FDA) untuk sistem sinar-X portabelnya, \u201cRAYMO.\u201d<\/p>\n\n\n\n<p style=\"margin-bottom:30px\">DRGEM mengumumkan pada tanggal 15 bahwa sistem sinar-X portabelnya, \u2018RAYMO,\u2019 telah memperoleh persetujuan dari FDA. Sertifikasi FDA AS dikenal karena proses peninjauannya yang ketat dan teliti; oleh karena itu, persetujuan ini menjadi bukti resmi bahwa keamanan dan keefektifan RAYMO melampaui standar global dan berada pada tingkat kelas dunia.<\/p>\n\n\n\n<p style=\"margin-bottom:50px\">RAYMO adalah sistem X-ray seluler generasi mendatang yang didasarkan pada desain yang ringan dan ringkas. Sistem ini meningkatkan mobilitas dan kenyamanan dengan menerapkan fitur-fitur yang berorientasi pada bidang medis dan dapat disesuaikan pengguna, seperti panduan getaran Collimator SID (Source-to-Image Distance), pemindai barcode, Radio Frequency Identification (RFID), dan kamera penggerak. Fitur utama lainnya adalah kemampuannya untuk memberikan pencitraan yang stabil dan efisien di berbagai lingkungan klinis.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"687\" src=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/DRGEM_RAYMO_FDA510kcleared-1024x687.png\" alt=\"\" class=\"wp-image-10699\" srcset=\"https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/DRGEM_RAYMO_FDA510kcleared-1024x687.png 1024w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/DRGEM_RAYMO_FDA510kcleared-300x201.png 300w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/DRGEM_RAYMO_FDA510kcleared-768x516.png 768w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/DRGEM_RAYMO_FDA510kcleared-18x12.png 18w, https:\/\/www.drgemhealthcare.com\/wp-content\/uploads\/2026\/05\/DRGEM_RAYMO_FDA510kcleared.png 1080w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-milestone-for-north-american-market-leadership\">Tonggak Strategis untuk Kepemimpinan Pasar Amerika Utara<\/h2>\n\n\n\n<p style=\"margin-bottom:50px\">\u201cPersetujuan dari FDA ini merupakan pencapaian yang berarti yang secara resmi mengakui keunggulan teknologi dan daya saing produk RAYMO,\u201d kata J.B. Park, CEO DRGEM. \u201cBerbekal pencapaian ini, kami akan memperluas kehadiran kami di pasar Amerika Utara dan berkembang menjadi mitra tepercaya di pasar peralatan pencitraan medis global.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-diversifying-the-digital-healthcare-portfolio\">Mendiversifikasi Portofolio Kesehatan Digital<\/h2>\n\n\n\n<p style=\"margin-bottom:50px\">DRGEM menyediakan solusi pencitraan medis digital, termasuk perangkat sinar-X digital, dengan fokus utama pada ekspor ke luar negeri. Belakangan ini, perusahaan telah memperluas portofolio bisnisnya dengan menambahkan perangkat lunak pencitraan digital dan sistem ultrasonografi. Dengan sertifikasi ini sebagai pendorong, perusahaan berencana untuk memperluas jangkauan pasarnya di Amerika Utara serta terus memperkuat strategi pasar globalnya dan pengembangan solusi pencitraan medis yang dioptimalkan untuk berbagai lingkungan medis.<\/p>\n\n\n\n<p><\/p>\n<\/div>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>DRGEM (CEO J.B. Park), a global medical imaging solutions company, is accelerating its expansion into the North American market after obtaining U.S. Food and Drug Administration (FDA) clearance for its mobile X-ray system, \u201cRAYMO.\u201d DRGEM announced on the 15th that its mobile X-ray system, \u2018RAYMO,\u2019 has received FDA clearance. The U.S. FDA certification is known [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":10690,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[14],"tags":[],"class_list":["post-10667","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drgem-news"],"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>FDA Clearance for DRGEM&#039;s RAYMO X-ray System - DRGEM<\/title>\n<meta name=\"description\" content=\"Discover the significance of FDA clearance for DRGEM&#039;s next-generation mobile X-ray system RAYMO and its market impact.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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