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U.S. Department of Health and Human Services

Product Classification

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Device colon computed tomography system, computer aided detection
Regulation Description Picture archiving and communications system.
Definition To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.
Physical State Computer based software
Technical Method Detection algorithm searches for and identifies potential polyps or other lesions on images of the colon acquired using multi-slice computed tomography (msct).
Target Area Colon
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeNWE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm187249.htm] 
Third Party Review Not Third Party Eligible
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