Product Classification

• Device: colon computed tomography system, computer aided detection
• Regulation Description: Medical image management and processing 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 Code: NWE
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging Devices and Electronic Products (DHT8B)
• Submission Type: 510(k)
• Regulation Number: 892.2050
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Guidance Document

• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible