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Introduction

  • Release Year: The Siemens Somatom Confidence RT Pro was introduced in 2016.

  • FDA Clearance: The device received FDA 510(k) clearance on December 20, 2016.

  • Introduction Event: The Somatom Confidence RT Pro was introduced at the 2016 annual meeting of the American Society for Radiation Oncology (ASTRO) in Boston.

Device Description [1]

  • Type: Computed Tomography (CT) system.

  • Design: Features a gantry large enough to allow imaging of any part of the body.

  • Imaging Capabilities: Produces two and/or three-dimensional (3-D) cross-sectional images.

  • Components: Includes single or multiple fixed annular arrays of x-ray tubes and opposing detectors.

  • Functionality: Capable of spiral CT and other special imaging applications.

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Technological Features [2]

  • Touch Panel Interface: Features a touch panel user interface for ease of use.

  • Stellar RT Detector: Includes a reduced width 2 cm Stellar RT Detector.

  • Software: Runs on software version SOMARIS/7 VA62A.

  • DirectDensity Algorithm: Provides CT images with an HU-like scaling nearly proportional to relative electron density.

  • Cybersecurity: Enhanced cybersecurity features to prevent unauthorized access and misuse.

Clinical Applications [3]

  • Radiation Therapy: Designed specifically for radiation therapy applications.

  • Tumor Contouring: Provides personalized images for optimal tumor and organs-at-risk contouring.

  • Dose Calculation: Images optimized for radiation therapy treatment dose calculation.

  • Low Dose Lung Cancer Screening: Can be used for low dose lung cancer screening in high-risk populations.

  • Moving Tumors: Advanced treatment of moving tumors with syngo.via RT Image Suite software.

Regulatory Information [2]

  • FDA Clearance: Received FDA 510(k) clearance on December 20, 2016.

  • Regulation Number: Classified under 21 CFR 892.1750.

  • Product Code: JAK.

  • Regulatory Class: Class II.

  • Compliance: Conforms to various performance standards including ISO 14791, NEMA XR-29, and IEC 61223-2-6.

Software and Algorithms [3]

  • syngo.via RT Image Suite: Supports advanced treatment of moving tumors.

  • DirectDensity Algorithm: Delivers electron density images independent of kV settings.

  • Iterative Reconstruction: Supports various optional iterative reconstruction methods.

  • Data Exchange: Facilitates data exchange with external software clients like Teamplay.

  • IT Hardening: Enhanced IT security features to protect against unauthorized access.

Environmental Conditions [1]

  • Handling Temperature: -20 to 50 degrees Celsius.

  • Handling Humidity: 10% to 90% relative humidity.

  • Handling Pressure: 70 to 106 kPa.

  • Storage Temperature: -20 to 50 degrees Celsius.

  • Storage Humidity: 10% to 90% relative humidity.

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