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K091529.pdf

K091529.pdf
Preview of K091529
🔗 Source: accessdata.fda.gov
📊 Size: 167 KB
📄 Pages: 6 pages
⬇️ Downloads: 47

Summary

iCAD, Inc. submitted a 510(k) premarket notification for VeraLook CTC CAD Software, a computer-aided detection system for computed tomographic colonography (CTC) exams. The device is intended to automatically detect potential polyps in CTC exams and highlight them to the interpreting physician. iCAD claims substantial equivalence to predicate devices, including Medicsight's Colon CAR 1.2 and Siemens' Syngo Colonography. The FDA determined the device is substantially equivalent to legally marketed predicate devices and may be marketed, subject to general controls provisions of the Act.

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Description

iCAD, Inc.

Technical Information

  • File Format: PDF
  • File Size: 167 KB
  • Pages: 6
  • Language: EN
  • Total Downloads: 47
  • Last Updated: 1 month ago

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