{"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\/zh\/promo-achieves-fda-510k-clearance\/","title":{"rendered":"DRGEM \u7684 PROMO \u79fb\u52a8 X \u5c04\u7ebf\u7cfb\u7edf\u901a\u8fc7\u7f8e\u56fd FDA 510(k) \u8ba4\u8bc1"},"content":{"rendered":"<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-black-color\">DRGEM \u5ba3\u5e03\u5176 PROMO \u79fb\u52a8 X \u5c04\u7ebf\u7cfb\u7edf\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u4f20\u7edf 510(k) \u8bb8\u53ef\u3002\u8fd9\u4e00\u91cc\u7a0b\u7891\u8bc1\u660e PROMO \u7b26\u5408\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u7684\u6240\u6709\u76d1\u7ba1\u8981\u6c42\uff0c\u5de9\u56fa\u4e86 DRGEM \u5728\u5168\u7403\u8bca\u65ad\u6210\u50cf\u9886\u57df\u7684\u9886\u5148\u5730\u4f4d\u3002<\/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\">\u9ad8\u6548\u7075\u6d3b\u7684\u79fb\u52a8 X \u5149\u673a<\/mark><\/h4>\n\n\n\n<p>PROMO \u5728\u5f00\u53d1\u65f6\u5145\u5206\u8003\u8651\u4e86\u4e34\u5e8a\u6548\u7387\u548c\u533b\u9662\u9700\u6c42\u3002\u8be5\u7cfb\u7edf\u8bbe\u8ba1\u8f7b\u5de7\uff0c\u53ef\u786e\u4fdd\u5728\u91cd\u75c7\u76d1\u62a4\u5ba4\u3001\u624b\u672f\u5ba4\u548c\u6025\u8bca\u79d1\u7b49\u72ed\u7a84\u7a7a\u95f4\u5185\u987a\u5229\u64cd\u63a7\u3002\u540c\u65f6\uff0c\u5b83\u7684\u6210\u50cf\u8986\u76d6\u9762\u5e7f\uff0c\u652f\u6301\u4ece\u5e38\u89c4\u80f8\u7247\u5230\u4e13\u4e1a\u5e8a\u65c1\u68c0\u67e5\u7b49\u591a\u79cd\u7528\u9014\u3002<\/p>\n\n\n\n<p>PROMO \u7684\u4e3b\u8981\u4f18\u70b9\u5305\u62ec<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u7ed3\u6784\u7d27\u51d1\uff0c\u4fbf\u4e8e\u79fb\u52a8<\/strong> - \u7ed3\u6784\u8f7b\u5de7\uff0c\u91c7\u7528\u4e0b\u63a8\u5f0f\u9a71\u52a8\uff0c\u5373\u4f7f\u5728\u72ed\u5c0f\u7684\u533b\u9662\u7a7a\u95f4\u5185\u4e5f\u80fd\u786e\u4fdd\u5e73\u7a33\u7684\u64cd\u63a7\u6027\u3002<strong><br><\/strong><\/li>\n\n\n\n<li><strong>\u7075\u6d3b\u5b9a\u4f4d<\/strong> - 180\u00b0 \u65cb\u8f6c\u67f1\u3001\u7075\u6d3b\u7684\u7ba1\u5934\u548c\u9ad8\u7126\u6591\u9ad8\u5ea6\u53ef\u6ee1\u8db3\u4e0d\u540c\u7684\u4e34\u5e8a\u9700\u6c42\uff0c\u63d0\u4f9b\u7cbe\u786e\u7684\u6210\u50cf\u3002<br><\/li>\n\n\n\n<li><strong>\u9ad8\u6548\u7684\u9ad8\u8d28\u91cf\u6210\u50cf<\/strong> - 40 kW \u7535\u5bb9\u53d1\u751f\u5668\u548c RADMAX \u8f6f\u4ef6\u53ef\u63d0\u4f9b\u6e05\u6670\u3001\u53ef\u9760\u7684\u56fe\u50cf\uff0c\u540c\u65f6\u652f\u6301\u53ca\u65f6\u3001\u7b80\u5316\u7684\u5de5\u4f5c\u6d41\u7a0b\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>DRGEM \u516c\u53f8\u603b\u88c1 J.B. Park \u5148\u751f\u5728\u8c08\u53ca\u6b64\u6b21\u6e05\u5173\u65f6\u8868\u793a\uff1a<\/p>\n\n\n\n<p><em>\"PROMO\u83b7\u5f97FDA 510(k)\u8ba4\u8bc1\uff0c\u6807\u5fd7\u7740\u6211\u4eec\u5728\u63d0\u4f9b\u4e16\u754c\u4e00\u6d41\u6210\u50cf\u89e3\u51b3\u65b9\u6848\u7684\u9053\u8def\u4e0a\u8fc8\u51fa\u4e86\u91cd\u8981\u4e00\u6b65\u3002PROMO \u7684\u5f00\u53d1\u662f\u4e3a\u4e86\u6ee1\u8db3\u4e34\u5e8a\u533b\u751f\u5728\u62a4\u7406\u70b9\u9700\u8981\u53ca\u65f6\u3001\u7075\u6d3b\u548c\u53ef\u9760\u6210\u50cf\u7684\u9700\u6c42\u3002PROMO \u96c6\u79fb\u52a8\u6027\u3001\u9ad8\u6548\u6027\u548c\u7ecf\u6d4e\u6027\u4e8e\u4e00\u8eab\uff0c\u53ef\u6539\u5584\u7f8e\u56fd\u53ca\u5176\u4ed6\u5730\u533a\u7684\u5e8a\u65c1\u6210\u50cf\u3002\u8be5\u4ea7\u54c1\u7684\u901a\u8fc7\u8868\u660e\u4e86\u6211\u4eec\u5bf9\u8d28\u91cf\u3001\u521b\u65b0\u548c\u6269\u5927\u5148\u8fdb\u533b\u5b66\u6210\u50cf\u670d\u52a1\u7684\u627f\u8bfa\u3002<\/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\">\u52a0\u5f3a DRGEM \u7684\u5168\u7403\u6218\u7565<\/mark><\/h4>\n\n\n\n<p>\u901a\u8fc7 FDA \u8ba4\u8bc1\u4e0d\u4ec5\u662f\u4e00\u4e2a\u76d1\u7ba1\u91cc\u7a0b\u7891\uff0c\u4e5f\u662f DRGEM \u957f\u671f\u613f\u666f\u7684\u6218\u7565\u8fdb\u6b65\u3002\u901a\u8fc7\u6ee1\u8db3\u4e25\u683c\u7684\u7f8e\u56fd\u76d1\u7ba1\u6807\u51c6\uff0cPROMO \u8bc1\u660e\u4e86 DRGEM \u5728\u6700\u5148\u8fdb\u7684\u533b\u7597\u6210\u50cf\u5e02\u573a\u4e0a\u7684\u7ade\u4e89\u80fd\u529b\u3002\u5b83\u517c\u987e\u4e86\u9ad8\u6027\u80fd\u548c\u6210\u672c\u6548\u76ca\uff0c\u662f\u533b\u9662\u548c\u8bca\u6240\u5728\u4e0d\u964d\u4f4e\u8d28\u91cf\u7684\u524d\u63d0\u4e0b\u63d0\u9ad8\u8bca\u65ad\u6548\u7387\u7684\u7406\u60f3\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n\n\n\n<p class=\"translation-block\">\u968f\u7740 DRGEM \u5728\u5168\u7403\u8303\u56f4\u5185\u7684\u4e0d\u65ad\u6269\u5c55\uff0cPROMO \u52a0\u5f3a\u4e86\u5176\u5148\u8fdb\u8bca\u65ad\u7cfb\u7edf\u7684\u4ea7\u54c1\u7ec4\u5408\uff0c\u76ee\u524d\u5df2\u5728 120 \u591a\u4e2a\u56fd\u5bb6\u5f97\u5230\u5e7f\u6cdb\u4fe1\u8d56\u3002\u8fd9\u4e00\u91cc\u7a0b\u7891\u518d\u6b21\u8bc1\u660e\u4e86 DRGEM \u81f4\u529b\u4e8e\u63d0\u4f9b\u5b8c\u6574\u7684\u6210\u50cf\u89e3\u51b3\u65b9\u6848\uff0c\u4ee5\u589e\u5f3a\u533b\u5b66\u5f71\u50cf\u4e13\u4e1a\u4eba\u5458\u7684\u80fd\u529b\u5e76\u6539\u5584\u60a3\u8005\u7684\u6cbb\u7597\u6548\u679c\u3002<\/p>\n\n\n\n<p>\u3000<\/p>\n\n\n\n<p>\u4e86\u89e3\u6709\u5173 PROMO \u7684\u66f4\u591a\u4fe1\u606f\uff1a <a href=\"http:\/\/www.drgemhealthcare.com\/zh\/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\/zh\/promo-achieves-fda-510k-clearance\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\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). 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