Samsung NeuroLogica's BodyTom 64 and OmniTom Elite Portable CT Scanners Gain FDA Clearance

FDA granted 510(k) clearance to Samsung NeuroLogica for the BodyTom 64 and OmniTom Elite portable CT systems, designed for point-of-care computed tomography imaging.

• The BodyTom 64 and OmniTom Elite are class II computed tomography x-ray systems (product code JAK) cleared via the FDA’s 510(k) premarket notification.
• Designed for point-of-care use, these portable CT scanners support intraoperative, emergency department, and bedside imaging.

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