{"id":401,"date":"2023-12-29T09:59:05","date_gmt":"2023-12-29T00:59:05","guid":{"rendered":"https:\/\/xn--950ba19ri1m.net\/?p=401"},"modified":"2023-12-29T09:59:05","modified_gmt":"2023-12-29T00:59:05","slug":"%eb%8c%80%ea%b5%ac%ea%b4%91%ec%97%ad%ec%8b%9c-3d%ed%94%84%eb%a6%b0%ed%8c%85-%ec%9d%98%eb%a3%8c%ea%b8%b0%ea%b8%b0-%ec%88%98%ec%b6%9c-1%eb%b2%88%ec%a7%80%eb%a1%9c-%eb%8f%84%ec%95%bd-%ec%84%b1%ea%b3%b5","status":"publish","type":"post","link":"https:\/\/xn--950ba19ri1m.net\/?p=401","title":{"rendered":"\ub300\uad6c\uad11\uc5ed\uc2dc, 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uc218\ucd9c 1\ubc88\uc9c0\ub85c \ub3c4\uc57d \uc131\uacf5"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-402\" src=\"http:\/\/xn--950ba19ri1m.net\/wp-content\/uploads\/2023\/12\/20231228142148-43724.jpg\" alt=\"\" width=\"509\" height=\"359\" srcset=\"https:\/\/xn--950ba19ri1m.net\/wp-content\/uploads\/2023\/12\/20231228142148-43724.jpg 509w, https:\/\/xn--950ba19ri1m.net\/wp-content\/uploads\/2023\/12\/20231228142148-43724-300x212.jpg 300w\" sizes=\"(max-width: 509px) 100vw, 509px\" \/><\/p>\n<p>\ub3d9\ub124\ubc29\ub124 \uae40\ud615\uaddc \uae30\uc790 | \ub300\uad6c\uad11\uc5ed\uc2dc\ub294 \uacbd\ubd81\ub300\ud559\uad50 \ucca8\ub2e8\uc815\ubcf4\ud1b5\uc2e0\uc735\ud569\uc0b0\uc5c5\uae30\uc220\uc6d0\uacfc \uc190\uc7a1\uace0 \u20183D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uc0c1\uc6a9\ud654 \uc2e4\uc99d\uc9c0\uc6d0 \uc0ac\uc5c5\u2019 \ub4f1\uc744 \ud1b5\ud574 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \ud574\uc678\uc218\ucd9c \uc9c0\uc6d0\uc744 \uc704\ud55c \uc0dd\uc0b0\uac70\uc810\uc744 \uad6c\ucd95\ud558\uace0, FDA \uc2dc\uc124 \ub4f1\ub85d(Establishment Registration) \ubc0f \uae30\uc5c5 \uc81c\ud488 \ub4f1\uc7ac(Device Listing)\uc5d0 \uc131\uacf5\ud574 \uad6d\ub0b4 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uc0b0\uc5c5\uc758 \ud574\uc678\uc2dc\uc7a5 \uac1c\ucc99 \ubc0f \uc218\ucd9c \uba54\uce74\ub85c \ubc1c\ub3cb\uc6c0\ud588\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>FDA 510(k)\ub294 \uc758\ub8cc\uae30\uae30 \uc2dc\ud310 \uc804(\u524d) \uae30\uc874 \ud5c8\uac00 \uc81c\ud488\uacfc \ub3d9\ub4f1\uc131\uc744 \ube44\uad50\ud574 \uc131\ub2a5\uc774 \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc774\ub77c\ub294 \uac83\uc744 \uac80\uc99d\ud558\ub294 FDA \ud5c8\uac00 \uc81c\ub3c4\ub85c\uc11c, \uacbd\ubd81\ub300 \ucca8\ub2e8\uae30\uc220\uc6d0\uacfc \uad6d\ub0b4 \uc758\ub8cc\uae30\uc5c5(\u321c\uc9c0\uc5d0\uc2a4\uba54\ub514\uce7c, \u321c\uc9c0\ube44\uc5d0\uc2a4\ucee4\uba3c\uc6f0\uc2a4) \uac04 \ud611\uc5c5\uc744 \ud1b5\ud574 \u2018\ucd94\uac04\uccb4\uc720\ud569\ubcf4\ud615\uc7ac\u2019 \ucd1d 3\uac1c \uc81c\ud488\uc774 FDA 510(k) \ud5c8\uac00\ub97c \ud68d\ub4dd\ud558\ub294 \uc131\uacfc\ub97c \uac70\ub480\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>\uc774\ubc88 \ud5c8\uac00\ub85c \uc9c0\uc5ed\uc5d0\uc11c \uc81c\uc870\ub418\ub294 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30\uac00 \uc758\ub8cc\uae30\uae30\ub85c\uc368 \uc548\uc804\uc131\uacfc \ud6a8\uacfc\uc131\uc774 \uacf5\uc2dd\uc801\uc73c\ub85c \uc785\uc99d\ub410\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>\ucca8\ub2e8 \uc758\ub8cc\uae30\uae30\ub85c \uac01\uad11\ubc1b\uace0 \uc788\ub294 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30\ub97c \uc81c\uc791\ud558\uae30 \uc704\ud574\uc11c\ub294 \uace0\uac00\uc758 3D\ud504\ub9b0\ud130 \uad6c\ucd95\uacfc \uc7a5\ube44 \uc6b4\uc601 \uacbd\ud5d8 \ubc0f \uc778\ud5c8\uac00 \ub178\ud558\uc6b0\uac00 \uc694\uad6c\ub418\ub294\ub370, \uc774\ub294 \uc601\uc138\ud55c \uc911\uc18c\uae30\uc5c5\uc758 \ucca8\ub2e8 \uc758\ub8cc\uc0b0\uc5c5 \uc9c4\ucd9c\uc5d0 \uc9c4\uc785\uc7a5\ubcbd\uc73c\ub85c \uc791\uc6a9\ud558\uace0 \uc788\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>\ub300\uad6c\uad11\uc5ed\uc2dc\ub294 \uc774\ub7ec\ud55c \uc560\ub85c\uc0ac\ud56d\uc744 \ud574\uc18c\ud558\uae30 \uc704\ud574 2015\ub144\ubd80\ud130 \uacbd\ubd81\ub300 \ucca8\ub2e8\uae30\uc220\uc6d0\uc744 \uc911\uc2ec\uc73c\ub85c 3D\ud504\ub9b0\ud305 \uc2e0\uae30\uc220\uc744 \ud65c\uc6a9\ud55c \ucca8\ub2e8 \uc758\ub8cc\uc0b0\uc5c5 \uc721\uc131\uacfc \uc0ac\uc5c5\ud654\ub97c \uc9c0\uc6d0\ud558\uace0 \uc788\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>\uacbd\ubd81\ub300 \ucca8\ub2e8\uae30\uc220\uc6d0\uc5d0\uc11c\ub294 3D\ud504\ub9b0\ud305\uc5d0 \ud544\uc694\ud55c \uc124\uacc4 \ubc0f \ub370\uc774\ud130 \uac80\uc99d, \uc81c\uc791 \ubc0f \ud6c4\ucc98\ub9ac, \uc138\ucc99 \ubc0f \ud3ec\uc7a5, \uc778\ud5c8\uac00 \ud68d\ub4dd \ub4f1 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uac1c\ubc1c\ubd80\ud130 \uc591\uc0b0\uae4c\uc9c0 \ubaa8\ub4e0 \uacfc\uc815\uc744 \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294 \uc2dc\uc2a4\ud15c\uc744 \uc6b4\uc601 \uc911\uc774\ub2e4. \ub610\ud55c \uc2dd\uc57d\ucc98 \uc81c\uc870\uc5c5\ud5c8\uac00, KGMP, ISO 13485, FDA \uc81c\uc870\uc2dc\uc124 \ub4f1\ub85d \ub4f1 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30\uc5d0 \uad00\ud55c \uad6d\ub0b4\uc678 \uc0ac\uc5c5\ud654 \uc9c0\uc6d0 \uae30\ubc18\uc744 \ud655\ubcf4\ud588\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>\ud2b9\ud788, \ucd5c\uadfc \u2018\uc591\uc0b0 \ud6a8\uc728\uc131 \uadf9\ub300\ud654\ub97c \uc704\ud55c 3D\ud504\ub9b0\ud305 \ucc99\ucd94\ucf00\uc774\uc9c0\uc758 \ub2e4\uce35 \uc801\uce35 \uacf5\uc815 \uae30\uc220\u2019 \uac1c\ubc1c\ub85c \uacfc\ud559\uae30\uc220\uc815\ubcf4\ud1b5\uc2e0\ubd80 \uc7a5\uad00\uc0c1\uc744 \uc218\uc0c1\ud574 3D\ud504\ub9b0\ud305 \uae30\uc220\ub825\uc744 \ub354\uc6b1\ub354 \uc778\uc815\ubc1b\uace0 \uc788\ub2e4.<\/p>\n<p>&nbsp;<\/p>\n<p>\ucd5c\uc6b4\ubc31 \ub300\uad6c\uad11\uc5ed\uc2dc \ubbf8\ub798\ud601\uc2e0\uc131\uc7a5\uc2e4\uc7a5\uc740 \u201c\uc758\ub8cc\uae30\uae30\ub294 \uc778\uc99d\uc758 \ubcbd\uc744 \ub118\uc9c0 \ubabb\ud558\uba74 \uc0ac\uc5c5\ud654\uac00 \ubd88\uac00\ub2a5\ud55c\ub370, \uc55e\uc73c\ub85c\ub3c4 \ub300\uad6c\uc2dc\ub294 R&amp;D\uc5d0\uc11c \uc0ac\uc5c5\ud654\uae4c\uc9c0 \uc804\uc8fc\uae30 \uc9c0\uc6d0\uc744 \ud1b5\ud574 \uc9c0\uc5ed \uc758\ub8cc\uae30\uc5c5\uc758 \uc5ed\ub7c9\uc744 \uac15\ud654\ud574 \uc138\uacc4 \uc2dc\uc7a5\uc744 \uc8fc\ub984\uc7a1\uc744 \uc218 \uc788\ub3c4\ub85d \uc801\uadf9 \uc9c0\uc6d0\ud558\uaca0\ub2e4\u201d\uace0 \ub9d0\ud588\ub2e4.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; \ub3d9\ub124\ubc29\ub124 \uae40\ud615\uaddc \uae30\uc790 | \ub300\uad6c\uad11\uc5ed\uc2dc\ub294 \uacbd\ubd81\ub300\ud559\uad50 \ucca8\ub2e8\uc815\ubcf4\ud1b5\uc2e0\uc735\ud569\uc0b0\uc5c5\uae30\uc220\uc6d0\uacfc \uc190\uc7a1\uace0 \u20183D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uc0c1\uc6a9\ud654 \uc2e4\uc99d\uc9c0\uc6d0 \uc0ac\uc5c5\u2019 \ub4f1\uc744 \ud1b5\ud574 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \ud574\uc678\uc218\ucd9c \uc9c0\uc6d0\uc744 \uc704\ud55c \uc0dd\uc0b0\uac70\uc810\uc744 \uad6c\ucd95\ud558\uace0, FDA \uc2dc\uc124 \ub4f1\ub85d(Establishment Registration) \ubc0f \uae30\uc5c5 \uc81c\ud488 \ub4f1\uc7ac(Device Listing)\uc5d0 \uc131\uacf5\ud574 \uad6d\ub0b4 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uc0b0\uc5c5\uc758 \ud574\uc678\uc2dc\uc7a5 \uac1c\ucc99 \ubc0f \uc218\ucd9c \uba54\uce74\ub85c \ubc1c\ub3cb\uc6c0\ud588\ub2e4. &nbsp; FDA 510(k)\ub294 \uc758\ub8cc\uae30\uae30 \uc2dc\ud310 \uc804(\u524d) \uae30\uc874 \ud5c8\uac00 \uc81c\ud488\uacfc \ub3d9\ub4f1\uc131\uc744 \ube44\uad50\ud574 \uc131\ub2a5\uc774 \uc548\uc804\ud558\uace0 &#8230; <a title=\"\ub300\uad6c\uad11\uc5ed\uc2dc, 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uc218\ucd9c 1\ubc88\uc9c0\ub85c \ub3c4\uc57d \uc131\uacf5\" class=\"read-more\" href=\"https:\/\/xn--950ba19ri1m.net\/?p=401\" aria-label=\"More on \ub300\uad6c\uad11\uc5ed\uc2dc, 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uc218\ucd9c 1\ubc88\uc9c0\ub85c \ub3c4\uc57d \uc131\uacf5\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[45,46,53,39,41,42,40,1],"tags":[353,13],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\ub300\uad6c\uad11\uc5ed\uc2dc, 3D\ud504\ub9b0\ud305 \uc758\ub8cc\uae30\uae30 \uc218\ucd9c 1\ubc88\uc9c0\ub85c \ub3c4\uc57d \uc131\uacf5 - \ub3d9\ub124\ubc29\ub124 \uc778\ud130\ub137\ub274\uc2a4<\/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:\/\/xn--950ba19ri1m.net\/?p=401\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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