{"id":51304,"date":"2022-11-28T17:03:01","date_gmt":"2022-11-28T16:03:01","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/neurologica-announces-fda-510k-clearance-of-bodytom-64\/"},"modified":"2022-11-28T17:03:01","modified_gmt":"2022-11-28T16:03:01","slug":"neurologica-announces-fda-510k-clearance-of-bodytom-64","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/neurologica-announces-fda-510k-clearance-of-bodytom-64\/","title":{"rendered":"NeuroLogica Announces FDA 510(k) Clearance of BodyTom\u00ae 64"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<b><i>The BodyTom<sup>\u00ae<\/sup> 64 was designed to help healthcare professionals bring the power of advanced imaging directly to their patients<\/i><\/b>\n<\/p>\n<p>DANVERS, Mass.&#8211;(BUSINESS WIRE)&#8211;NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced that its head-to-toe trauma imaging solution, the BodyTom<sup>\u00ae<\/sup> 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, has received 510(k) clearance from the U.S. Food and Drug Administration for commercial use in the United States.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221128005195\/en\/1647589\/5\/BodyTom_64_withShadow_brighter.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221128005195\/en\/1647589\/21\/BodyTom_64_withShadow_brighter.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20221128005195\/en\/1647588\/5\/NeuroLogica-logo-2013.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221128005195\/en\/1647588\/21\/NeuroLogica-logo-2013.jpg\"><\/a><\/p>\n<p>\n\u201cWe\u2019re thrilled to build off our expertise and elevate point-of-care imaging with our BodyTom 64, which can transform any room in a hospital into an advanced imaging suite,\u201d said Jason Koshnitsky, Sr. Director of Global Sales and Marketing of NeuroLogica. \u201cThis full-body 64-slice CT scanner is an upgraded version of the BodyTom Elite CT scanner, providing enhanced functionality with the same high-resolution imaging capabilities.\u201d\n<\/p>\n<p>\nBased on customer feedback, the company designed the BodyTom 64 to enhance the user experience and improve clinical workflows through revisions to both the software and the data acquisition system (DAS). Such revisions include incorporating Linux as the operating system and having the ability to generate up to 64 cross-sectional CT images of a patient\u2019s body, versus the 32 images produced by the predicate BodyTom<sup>\u00ae<\/sup> Elite.\n<\/p>\n<p>\nWith indications for both pediatric and adult imaging, the BodyTom 64 is a multi-departmental imaging solution that can be utilized for various needs, including:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Neurosurgery\/Surgery:<\/b> When combined with any radiolucent skull fixation device, the BodyTom 64 can transform an operating room into an intraoperative neuro-imaging suite to enhance neuro-navigation and surgical outcomes, including clinical utility for extracranial procedures.\n<\/li>\n<li>\n<b>Trauma\/ER:<\/b> The BodyTom 64\u2019s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite.\n<\/li>\n<li>\n<b>Interventional Radiology:<\/b> BodyTom 64 can help optimize workflows by remaining ready to rescan for each stage of needle guidance, and bring the power of multi-slice CT to the interventional suite.\n<\/li>\n<\/ul>\n<p>\nThe BodyTom 64 brings the power of innovative imaging to patients\u2019 bedsides safely and efficiently. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards.\n<\/p>\n<p>\nTo learn more about the BodyTom 64, please visit: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.neurologica.com%2F&amp;esheet=52979055&amp;newsitemid=20221128005195&amp;lan=en-US&amp;anchor=www.NeuroLogica.com&amp;index=1&amp;md5=d18b4cf0728bdc7770e28a403568c6a5\" rel=\"nofollow noopener\" shape=\"rect\">www.NeuroLogica.com<\/a>\n<\/p>\n<p>\n<b>About NeuroLogica<\/b>\n<\/p>\n<p>\nNeuroLogica Corp., the healthcare subsidiary of Samsung Electronics Co., Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography devices. NeuroLogica\u2019s growing portfolio of advanced medical technologies is used worldwide in leading healthcare institutions helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. For more information, please visit: <b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.neurologica.com%2F&amp;esheet=52979055&amp;newsitemid=20221128005195&amp;lan=en-US&amp;anchor=www.NeuroLogica.com&amp;index=2&amp;md5=e37858c1343fda246c122a1adbb1c461\" rel=\"nofollow noopener\" shape=\"rect\">www.NeuroLogica.com<\/a><\/b>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Inquiries<\/b><br \/>Jason Koshnitsky, Sr. Director Global Sales &amp; Marketing<br \/>\n<br \/>NeuroLogica<br \/>\n<br \/>508.904.3819<br \/>\n<br \/><a target=\"_blank\" href=\"mailto:jkoshnitsky&#64;neuro&#108;&#111;&#103;&#105;&#99;&#97;&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">j&#107;&#111;&#x73;&#x68;n&#105;&#116;&#x73;&#x6b;&#x79;&#64;&#110;&#101;&#x75;&#x72;ol&#111;&#x67;&#x69;&#x63;a&#46;&#99;&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The BodyTom\u00ae 64 was designed to help healthcare professionals bring the power of advanced imaging directly to their patients DANVERS, Mass.&#8211;(BUSINESS WIRE)&#8211;NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced that its head-to-toe trauma imaging solution, the BodyTom\u00ae 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, has received 510(k) clearance from the U.S. Food and &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/neurologica-announces-fda-510k-clearance-of-bodytom-64\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-51304","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>NeuroLogica Announces FDA 510(k) Clearance of BodyTom\u00ae 64 - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/neurologica-announces-fda-510k-clearance-of-bodytom-64\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NeuroLogica Announces FDA 510(k) Clearance of BodyTom\u00ae 64 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"The BodyTom\u00ae 64 was designed to help healthcare professionals bring the power of advanced imaging directly to their patients DANVERS, Mass.&#8211;(BUSINESS WIRE)&#8211;NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., announced that its head-to-toe trauma imaging solution, the BodyTom\u00ae 64 Point-of-Care Mobile Computed Tomography (CT) Scanner, has received 510(k) clearance from the U.S. Food and ... 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