MRI2CT's NextMR Spine Gains FDA 510(k) Clearance

The FDA cleared NextMR Spine (MRI2CT, Inc.) via the 510(k) pathway. The radiological image processing system (product code QIH) was reviewed under the Radiology committee.

• The device is a radiological image processing system under FDA product code QIH.
• Clearance was obtained through the 510(k) premarket notification pathway.
• The applicant is MRI2CT, Inc., and the FDA review committee was Radiology.

Automated summary

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