NeuroLogica Earns FDA Clearance for BodyTom 64 CT Scanner

Revisions include incorporating Linux as the operating system and having the ability to generate up to 64 cross-sectional CT images of a patient’s body.

Body Tom 64 With Shadow Brighter
NeuroLogica

NeuroLogica, a subsidiary of Samsung Electronics, announced that its head-to-toe trauma imaging solution, the BodyTom 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.

Based 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’s body, versus the 32 images produced by the predicate BodyTom Elite.

With indications for both pediatric and adult imaging, the BodyTom 64 is a multi-departmental imaging solution that can be utilized for various needs, including:

  • Neurosurgery/Surgery: 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.
  • Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite.
  • Interventional Radiology: 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.

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.

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