{"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\/ko\/promo-achieves-fda-510k-clearance\/","title":{"rendered":"\ub514\uc54c\uc82c \uc774\ub3d9\ud615 X-ray \uc2dc\uc2a4\ud15c PROMO, \ubbf8\uad6d FDA 510(k) \uc778\ud5c8\uac00 \ud68d\ub4dd"},"content":{"rendered":"<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">\ub514\uc54c\uc82c\uc740 \uc790\uc0ac\uc758 PROMO \uc774\ub3d9\ud615 X-ray \uc2dc\uc2a4\ud15c\uc774 \ubbf8\uad6d FDA 510(k) \uc778\ud5c8\uac00\ub97c \ud68d\ub4dd\ud588\ub2e4\uace0 \ubc1c\ud45c\ud588\ub2e4. \uc774\ubc88 \uc131\uacfc\ub294 PROMO\uac00 \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\uc785\uc5d0 \ud544\uc694\ud55c \ubaa8\ub4e0 \uaddc\uc81c \uc694\uac74\uc744 \ucda9\uc871\ud588\uc74c\uc744 \uc785\uc99d\ud558\uba70, \uae00\ub85c\ubc8c \uc9c4\ub2e8 \uc601\uc0c1 \ubd84\uc57c\uc5d0\uc11c \ub514\uc54c\uc82c\uc758 \uc785\uc9c0\ub97c \ud55c\uce35 \uac15\ud654\ud558\ub294 \uc911\uc694\ud55c \uc774\uc815\ud45c\uac00 \ub410\ub2e4.<\/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\">\uc784\uc0c1 \ud6a8\uc728\uc131\uacfc \uc720\uc5f0\uc131\uc744 \uac16\ucd98 \uc774\ub3d9\ud615 X-ray<\/mark><\/h4>\n\n\n\n<p>PROMO\ub294 \uc784\uc0c1 \ud6a8\uc728\uc131\uacfc \ubcd1\uc6d0\uc758 \uc2e4\uc81c \uc694\uad6c\ub97c \ucda9\uc871\ud558\uae30 \uc704\ud574 \uac1c\ubc1c\ub410\ub2e4. \uacbd\ub7c9\ud654\ub41c \uc124\uacc4\ub85c \uc911\ud658\uc790\uc2e4(ICU), \uc218\uc220\uc2e4(OR), \uc751\uae09\uc2e4(ER) \ub4f1 \ud611\uc18c\ud55c \uacf5\uac04\uc5d0\uc11c\ub3c4 \uc6d0\ud65c\ud55c \uc870\uc791\uc774 \uac00\ub2a5\ud558\uba70, \ub113\uc740 \ucd2c\uc601 \ubc94\uc704\ub97c \uc9c0\uc6d0\ud574 \uc77c\uc0c1\uc801\uc778 \ud749\ubd80 \ucd2c\uc601\ubd80\ud130 \ud2b9\uc218\ud55c \ubcd1\uc0c1 \uac80\uc0ac\uae4c\uc9c0 \ub2e4\uc591\ud55c \ud65c\uc6a9\uc774 \uac00\ub2a5\ud558\ub2e4.<\/p>\n\n\n\n<p>PROMO\uc758 \uc8fc\uc694 \uc7a5\uc810\uc740 \ub2e4\uc74c\uacfc \uac19\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ucef4\ud329\ud2b8 &amp; \ubaa8\ubc14\uc77c<\/strong> - \ud478\uc2dc \ub2e4\uc6b4 \uc564 \uace0 \uad6c\ub3d9 \ubc29\uc2dd\uc758 \uacbd\ub7c9 \uad6c\uc870\ub85c \ubcd1\uc6d0 \ub0b4 \uc881\uc740 \uacf5\uac04\uc5d0\uc11c\ub3c4 \uc6d0\ud65c\ud55c \uc774\ub3d9\uc131\uc744 \uc81c\uacf5\ud55c\ub2e4.<strong><br><\/strong><\/li>\n\n\n\n<li><strong>\uc720\uc5f0\ud55c \ud3ec\uc9c0\uc154\ub2dd<\/strong> - 180\u00b0 \ud68c\uc804 \uceec\ub7fc, \uc720\uc5f0\ud55c \ud29c\ube0c \ud5e4\ub4dc, \ub192\uc740 \ucd08\uc810 \uc704\uce58\ub97c \ud1b5\ud574 \uc815\ud655\ud558\uace0 \ub2e4\uc591\ud55c \ucd2c\uc601\uc744 \uc9c0\uc6d0\ud55c\ub2e4.<br><\/li>\n\n\n\n<li><strong>\uace0\ud488\uc9c8 \uc601\uc0c1 &amp; \ud6a8\uc728\uc131<\/strong> - 40kW \ucee4\ud328\uc2dc\ud130 \uc81c\ub108\ub808\uc774\ud130\uc640 RADMAX \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub85c \uc120\uba85\ud558\uace0 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc601\uc0c1\uc744 \uc81c\uacf5\ud558\ub294 \ub3d9\uc2dc\uc5d0, \uc2e0\uc18d\ud558\uace0 \uc77c\uad00\ub41c \uc6cc\ud06c\ud50c\ub85c\uc6b0\ub97c \uad6c\ud604\ud55c\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>\uc774\ubc88 \ud5c8\uac00\uc5d0 \ub300\ud574 \ub514\uc54c\uc82c \ubc15\uc815\ubcd1 \ub300\ud45c\uc774\uc0ac\ub294 \ub2e4\uc74c\uacfc \uac19\uc774 \ubc1d\ud614\ub2e4:<\/p>\n\n\n\n<p><em>\"PROMO\uc758 FDA 510(k) \uc778\ud5c8\uac00\ub294 \uc138\uacc4\uc801 \uc218\uc900\uc758 \uc601\uc0c1 \uc194\ub8e8\uc158\uc744 \uc81c\uacf5\ud558\ub824\ub294 \ub2f9\uc0ac\uc758 \ube44\uc804\uc744 \uc2e4\ud604\ud558\ub294 \uc911\uc694\ud55c \uc131\uacfc\uc785\ub2c8\ub2e4. PROMO\ub294 \uc2dc\uc758\uc801\uc808\ud558\uace0 \uc720\uc5f0\ud558\uba70 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \ubcd1\uc0c1 \ucd2c\uc601\uc744 \ud544\uc694\ub85c \ud558\ub294 \uc758\ub8cc\uc9c4\uc758 \uc694\uad6c\ub97c \ucda9\uc871\ud558\uae30 \uc704\ud574 \uac1c\ubc1c\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub3d9\uc131, \ud6a8\uc728\uc131, \uacbd\uc81c\uc131\uc744 \uac16\ucd98 PROMO\ub294 \ubbf8\uad6d\uc740 \ubb3c\ub860 \uc804 \uc138\uacc4\uc5d0\uc11c \ubcd1\uc0c1 \ucd2c\uc601 \ud658\uacbd\uc744 \uac1c\uc120\ud558\ub294 \ub370 \uae30\uc5ec\ud560 \uac83\uc785\ub2c8\ub2e4. \uc774\ubc88 \uc778\ud5c8\uac00\ub294 \ud488\uc9c8 \ubc0f \ud601\uc2e0, \ucca8\ub2e8 \uc758\ub8cc \uc601\uc0c1\uc758 \uc811\uadfc\uc131 \ud655\ub300\uc5d0 \ub300\ud55c \ub514\uc54c\uc82c\uc758 \ud655\uace0\ud55c \uc758\uc9c0\ub97c \ubcf4\uc5ec\uc90d\ub2c8\ub2e4.\"<\/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\">\ub514\uc54c\uc82c\uc758 \uae00\ub85c\ubc8c \uc804\ub7b5 \uac15\ud654<\/mark><\/h4>\n\n\n\n<p>\uc774\ubc88 FDA \uc778\ud5c8\uac00\ub294 \ub2e8\uc21c\ud55c \uaddc\uc81c \uc808\ucc28\ub97c \ub118\uc5b4, \ub514\uc54c\uc82c\uc758 \uc7a5\uae30\uc801 \ube44\uc804\uc744 \uc2e4\ud604\ud558\uae30 \uc704\ud55c \uc804\ub7b5\uc801 \ub3c4\uc57d\uc774\ub2e4. PROMO\ub294 \uae4c\ub2e4\ub85c\uc6b4 \ubbf8\uad6d \uaddc\uc81c \uae30\uc900\uc744 \ucda9\uc871\ud568\uc73c\ub85c\uc368 \ub514\uc54c\uc82c\uc774 \uc138\uacc4 \ucd5c\uace0 \uc218\uc900\uc758 \uc9c4\ub2e8 \uc601\uc0c1 \uc2dc\uc7a5\uc5d0\uc11c \uacbd\uc7c1\ud560 \uc218 \uc788\ub294 \uc5ed\ub7c9\uc744 \uc785\uc99d\ud588\ub2e4. \uc6b0\uc218\ud55c \uc131\ub2a5\uacfc \ube44\uc6a9 \ud6a8\uc728\uc131\uc744 \uacb8\ube44\ud55c \uc774 \uc2dc\uc2a4\ud15c\uc740 \ubcd1\uc6d0\uacfc \ud074\ub9ac\ub2c9\uc774 \uc9c4\ub2e8 \ud6a8\uc728\uc131\uc744 \ub192\uc774\uba74\uc11c\ub3c4 \ud488\uc9c8\uc744 \uc720\uc9c0\ud560 \uc218 \uc788\ub294 \ucd5c\uc801\uc758 \uc194\ub8e8\uc158\uc73c\ub85c \uc790\ub9ac\ub9e4\uae40\ud55c\ub2e4.<\/p>\n\n\n\n<p class=\"translation-block\">\ub514\uc54c\uc82c\uc740 \uae00\ub85c\ubc8c \uc2dc\uc7a5\uc5d0\uc11c\uc758 \uc785\uc9c0\ub97c \uafb8\uc900\ud788 \ud655\ub300\ud558\uace0 \uc788\uc73c\uba70, PROMO\ub294 \uc774\ubbf8 \uc804 \uc138\uacc4 120\uc5ec \uac1c\uad6d\uc5d0\uc11c \uc2e0\ub8b0\ubc1b\ub294 \ub514\uc54c\uc82c\uc758 \uc9c4\ub2e8 \uc601\uc0c1 \uc2dc\uc2a4\ud15c \ud3ec\ud2b8\ud3f4\ub9ac\uc624\ub97c \ub354\uc6b1 \uac15\ud654\ud55c\ub2e4. \uc774\ubc88 \uc131\uacfc\ub294 \uc758\ub8cc \uc601\uc0c1 \uc804\ubb38\uac00\ub97c \uc9c0\uc6d0\ud558\uace0 \ud658\uc790 \uc9c4\ub8cc\uc758 \uc9c8\uc744 \ub192\uc774\ub824\ub294 \ub514\uc54c\uc82c\uc758 \uc758\uc9c0\ub97c \ubcf4\uc5ec\uc900\ub2e4.<\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>PROMO\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\uae30: <a href=\"http:\/\/www.drgemhealthcare.com\/ko\/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\/ko\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\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\/ko\/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=\"\uae00\uc4f4\uc774\" \/>\n\t<meta name=\"twitter:data1\" content=\"mhpark\" \/>\n\t<meta name=\"twitter:label2\" content=\"\uc608\uc0c1 \ub418\ub294 \ud310\ub3c5 \uc2dc\uac04\" \/>\n\t<meta name=\"twitter:data2\" content=\"3\ubd84\" \/>\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\":\"ko-KR\"},{\"@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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