FDA 510(k) Clearance.pdf

K202280.pdf
Preview of FDA 510(k) Clearance
🔗 Source: accessdata.fda.gov
📊 Size: 898 KB
📄 Pages: 9 pages
⬇️ Downloads: 268

Summary

The FDA has determined that Cleerly Labs v2.0 is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general controls provisions of the Act, for use as an interactive tool for viewing and analyzing cardiac computed tomography data to determine the presence and extent of coronary plaques and stenosis in patients who underwent Coronary Computed Tomography Angiography.

Description

The FDA has determined that Cleerly Labs v2.0 is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general...

Technical Information

  • File Format: PDF
  • File Size: 898 KB
  • Pages: 9
  • Language: EN
  • Total Downloads: 268
  • Last Updated: 5 hours ago

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