{"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%a8%ba%e6%96%ad%e7%94%a8-x-%e7%b7%9a%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-diagnostic-x-ray-guidance\/","title":{"rendered":"\u7c73\u56fd FDA \u304c\u300cAssembler&#039;s Guide\u300d\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c"},"content":{"rendered":"<div>\n<div>\u3053\u306e\u6587\u66f8\u306f\u3001\u300c\u8a3a\u65ad\u7528 X \u7dda\u6a5f\u5668\u306e\u7d44\u307f\u7acb\u3066\u696d\u8005\u30ac\u30a4\u30c9: \u9023\u90a6\u6027\u80fd\u57fa\u6e96\u306b\u57fa\u3065\u304f\u8a3a\u65ad\u7528 X \u7dda\u6a5f\u5668\u306e\u7d44\u307f\u7acb\u3066\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\u3001\u304a\u3088\u3073\u30c7\u30a3\u30fc\u30e9\u30fc\u306e\u8cac\u4efb\u300d(DHHS \u51fa\u7248\u7269 FDA 81-8144\u30011980 \u5e74 11 \u6708) \u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u3059\u3002<\/div>\n<div><\/div>\n<div>\u3053\u306e\u898f\u683c\u306f\u3001\u8a3a\u65ad\u7528 X \u7dda\u88c5\u7f6e\u306e\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u7d44\u307f\u7acb\u3066\u696d\u8005\u306e\u4e00\u822c\u7684\u306a\u8cac\u4efb\u3068\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u8a3a\u65ad\u7528 X \u7dda\u88c5\u7f6e\u306e\u7d44\u307f\u7acb\u3066\u306b\u95a2\u3059\u308b\u30dd\u30ea\u30b7\u30fc\u306b\u95a2\u3059\u308b\u63a8\u5968\u4e8b\u9805\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/div>\n<div><\/div>\n<div>\u8a3a\u65ad\u7528 X \u7dda\u88c5\u7f6e\u306e\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u7d44\u307f\u7acb\u3066\u696d\u8005\u306f\u3001\u3053\u306e\u63a8\u5968\u4e8b\u9805\u304c\u3053\u306e\u554f\u984c\u306b\u95a2\u3059\u308b FDA \u306e\u73fe\u5728\u306e\u8003\u3048\u3092\u8868\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u3053\u308c\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/div>\n<\/div>\n<div><\/div>\n<div>\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u77e5\u308a\u305f\u3044\u3067\u3059\u304b? <a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">RegASK \u306e\u5c02\u9580\u5bb6\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/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>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-751274648\">\n\n\t<div id=\"col-1771445981\" 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\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/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 equipment. Manufacturers and assemblers of diagnostic x-ray equipment should consider these recommendations as it represents the current thinking of the FDA on the topic. Need to know more about Medical Devices regulation changes? Get in touch with RegASK\u2019s experts.<\/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 v27.3 (Yoast SEO v27.4) - 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. Stay compliant with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/ja\/fda-\u8a3a\u65ad\u7528-x-\u7dda\u30ac\u30a4\u30c0\u30f3\u30b9\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Issues Guidance of &quot;Assembler&#039;s Guide to Diagnostic X-Ray Equipment&quot;\" \/>\n<meta property=\"og:description\" content=\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/fda-\u8a3a\u65ad\u7528-x-\u7dda\u30ac\u30a4\u30c0\u30f3\u30b9\/\" \/>\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=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\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\":\"ja\"},{\"@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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