FDA Clears AZmed's Rayvolve AZchest Chest X-ray CAD Device

FDA cleared Rayvolve AZchest (AZmed), a computer-aided detection device for chest radiographs, through the 510(k) pathway under radiology product code QBS.

• Cleared via the FDA's 510(k) premarket notification process.
• Assigned product code QBS, which covers radiology computer-aided detection systems.
• Reviewed by the FDA's radiology devices review division.

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