{"id":4139,"date":"2023-03-07T08:08:08","date_gmt":"2023-03-07T00:08:08","guid":{"rendered":"https:\/\/regask.com\/?p=4139"},"modified":"2024-10-15T00:55:10","modified_gmt":"2024-10-14T16:55:10","slug":"fda-%e8%af%8a%e6%96%ad-x-%e5%b0%84%e7%ba%bf%e6%8c%87%e5%af%bc","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-diagnostic-x-ray-guidance\/","title":{"rendered":"\u7f8e\u56fdFDA\u53d1\u5e03\u300a\u7ec4\u88c5\u5546\u6307\u5357\u300b\u2026"},"content":{"rendered":"<div>\n<div>\u672c\u6587\u4ef6\u53d6\u4ee3\u4e86\u300a\u8bca\u65ad X \u5c04\u7ebf\u8bbe\u5907\u88c5\u914d\u5de5\u6307\u5357\uff1a\u8054\u90a6\u6027\u80fd\u6807\u51c6\u4e0b\u8bca\u65ad X \u5c04\u7ebf\u8bbe\u5907\u88c5\u914d\u5de5\u3001\u5206\u9500\u5546\u548c\u7ecf\u9500\u5546\u7684\u8d23\u4efb\u300b\uff08DHHS \u51fa\u7248\u7269 FDA 81-8144\uff0c1980 \u5e74 11 \u6708\uff09\u3002<\/div>\n<div><\/div>\n<div>\u5b83\u4e3a\u8bca\u65adX\u5c04\u7ebf\u8bbe\u5907\u5236\u9020\u5546\u548c\u7ec4\u88c5\u5546\u7684\u4e00\u822c\u8d23\u4efb\u4ee5\u53ca\u7ecf\u8ba4\u8bc1\u7684\u8bca\u65adX\u5c04\u7ebf\u8bbe\u5907\u7684\u7ec4\u88c5\u653f\u7b56\u63d0\u4f9b\u4e86\u5efa\u8bae\u3002<\/div>\n<div><\/div>\n<div>\u8bca\u65adX\u5c04\u7ebf\u8bbe\u5907\u7684\u5236\u9020\u5546\u548c\u7ec4\u88c5\u5546\u5e94\u8be5\u8003\u8651\u8fd9\u4e9b\u5efa\u8bae\uff0c\u56e0\u4e3a\u5b83\u4ee3\u8868\u4e86 FDA \u5bf9\u8be5\u4e3b\u9898\u7684\u5f53\u524d\u60f3\u6cd5\u3002<\/div>\n<\/div>\n<div><\/div>\n<div>\u9700\u8981\u4e86\u89e3\u66f4\u591a\u6709\u5173\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u53d8\u5316\u7684\u4fe1\u606f\u5417\uff1f <a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">\u4e0e RegASK \u7684\u4e13\u5bb6\u53d6\u5f97\u8054\u7cfb\u3002<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u66f4\u591a\u8be6\u60c5\u8bf7\u8054\u7cfb RegASK<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-x-ray-equipment\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-275429974\">\n\n\t<div id=\"col-566925065\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/zh\/%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-2\/%e8%b5%84%e6%ba%90-%e6%a1%88%e4%be%8b%e7%a0%94%e7%a9%b6-%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u533b\u7597\u5668\u68b0\u884c\u4e1a\u6848\u4f8b\u7814\u7a76<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>This document supersedes Assembler&#8217;s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers of diagnostic x-ray equipment under the federal performance standard (DHHS Publication FDA 81-8144, November 1980). It provides recommendations on the general responsibilities of manufacturers and assemblers of diagnostic x-ray equipment and the policy on the assembly of certified diagnostic x-ray&#8230;<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Diagnostic X-Ray Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. 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Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/fda-\u8bca\u65ad-x-\u5c04\u7ebf\u6307\u5bfc\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-03-07T00:08:08+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-14T16:55:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Issues Guidance of &#8220;Assembler&#8217;s Guid&hellip;\",\"datePublished\":\"2023-03-07T00:08:08+00:00\",\"dateModified\":\"2024-10-14T16:55:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\"},\"wordCount\":172,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/\",\"name\":\"FDA Diagnostic X-Ray Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-diagnostic-x-ray-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-03-07T00:08:08+00:00\",\"dateModified\":\"2024-10-14T16:55:10+00:00\",\"description\":\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. 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