Product Classification

• Device: lung 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 chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
• Physical State: Software device.
• Technical Method: Detection algorithm searches for and identifies potential nodules on images of the chest acquired using multi-slice computed tomography (msct).
• Target Area: Lung
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: OEB
• 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