Product Classification

• Device: lung 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 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
• Submission Type: 510(k)
• Regulation Number: 892.2050
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-44 Edition 3.0 2009-02 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
• IEC 60601-2-44 Edition 3.0 2012-08 Amendment 1 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

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  

Third Party Review

Not Third Party Eligible