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Devices Sold Online Through eBay a Growing Problem for US FDA The U.S. Food and Drug Administration (FDA) is facing a growing trend of consumers purchasing medical devices online... UK Launches Initiative Encouraging Development of Novel Technologies In its latest initiative to encourage the development of innovative devices, the UK’s Medicines and Healthcare... US Devicemakers Expected to Help in Fight Against Counterfeits Devicemakers would have to do their share to fight against counterfeits under a strategic plan aimed at protecting U.S.... Facility Licensing Problems Top Canada’s List of Noncompliances Establishment license renewal submissions and complaint handling are the leading noncompliance issues noted in Health... Global Shortage May Ease as NRU Resumes Producing Radioisotopes The global shortage of a commonly used diagnostic radioisotope may finally be coming to an end. Proposed US Bill Could Be Burden for Some Foreign Devicemakers A bill intended to protect against faulty imports could discourage foreign devicemakers from marketing their products in... UK’s CAC Postmarket Vigilance Rules Are Now in Line With the EU’s MDD Manufacturers of cardiac ablation catheters (CAC) marketed in the UK must have procedures in place to detect and report... Canada Delays STED Requirement for Device License Applications Health Canada is postponing full implementation of summary technical documentation (STED) for premarket license... EC Updates Classification Guidance to Reflect Changes in the MDD Manufacturers should consider all of a device’s characteristics when determining its classification in the EU,... Industry: Australia’s New Regs for IVDs Could Prove Costly Compliance with Australia’s new in vitro diagnostic (IVD) regulations could cost industry upwards of U.S. $42...

FDA News Feeds

Devices Sold Online Through eBay a Growing Problem for US FDA
The U.S. Food and Drug Administration (FDA) is facing a growing trend of consumers purchasing medical devices online...
UK Launches Initiative Encouraging Development of Novel Technologies
In its latest initiative to encourage the development of innovative devices, the UK’s Medicines and Healthcare...
US Devicemakers Expected to Help in Fight Against Counterfeits
Devicemakers would have to do their share to fight against counterfeits under a strategic plan aimed at protecting U.S....
Facility Licensing Problems Top Canada’s List of Noncompliances
Establishment license renewal submissions and complaint handling are the leading noncompliance issues noted in Health...
Global Shortage May Ease as NRU Resumes Producing Radioisotopes
The global shortage of a commonly used diagnostic radioisotope may finally be coming to an end.
Proposed US Bill Could Be Burden for Some Foreign Devicemakers
A bill intended to protect against faulty imports could discourage foreign devicemakers from marketing their products in...
UK’s CAC Postmarket Vigilance Rules Are Now in Line With the EU’s MDD
Manufacturers of cardiac ablation catheters (CAC) marketed in the UK must have procedures in place to detect and report...
Canada Delays STED Requirement for Device License Applications
Health Canada is postponing full implementation of summary technical documentation (STED) for premarket license...
EC Updates Classification Guidance to Reflect Changes in the MDD
Manufacturers should consider all of a device’s characteristics when determining its classification in the EU,...
Industry: Australia’s New Regs for IVDs Could Prove Costly
Compliance with Australia’s new in vitro diagnostic (IVD) regulations could cost industry upwards of U.S. $42...

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Practical Evaluation of Image Quality in Computed Radiographic (CR) Imaging Systems

Practical Evaluation of Image Quality (421.89 kB)

Authors: Nikunj Desai, Abhinav Singh, and Daniel J Valentino
Proceedings of SPIE Medical Imaging 2010
Date: February, 2010
ABSTRACT
A number of complementary metrics are available to assess the performance of digital X-ray imaging systems. However, the sensitivity of these metrics to changes in the electro-optical imaging chain is poorly understood. Some of the commonly used metrics include Contrast to Noise ratio (CNR), limiting spatial resolution, Modulation Transfer Function (MTF), Noise Power Spectrum (NPS) and the Detective Quantum Efficiency (DQE). We evaluated the utility of these metrics in characterizing the imaging plate, imaging system optics and electronic components of computed radiography (CR) systems. We developed practical and easy to use test objects (phantoms) and implemented software to aid in calculating each metric. The results of this research will facilitate the characterization of differences in CR systems using the appropriate metrics.

Performance Characterization of Computed Radiography based Mammography Systems

Performance Characterization of Computed Radiography (638.08 kB)

Authors: Abhinav Singh, Nikunj Desai and Daniel J Valentino
Proceedings of SPIE Medical Imaging 2010
Date: February, 2010
ABSTRACT
Computed Radiography (CR) is a cost-effective technology for digital mammography. In order to optimize the quality of images obtained using CR Mammography, we characterized the effect on image quality of the electrooptical components of the CR imaging chain. The metrics used to assess the image quality included the Contrast to Noise Ratio (CNR), Modulation Transfer Function (MTF), Noise Power Spectrum (NPS), Detective Quantum Efficiency (DQE) and Contrast Detail Response Phantom (CDMAM 3.4 Artinis Medical Systems). An 18x24 cm high-resolution granular phosphor imaging plate (AGFA MM3.0) was used to acquire the images. Contrast detail was measured using a GUI developed for the CDMAM phantom that was scored by independent observers. The range of theoretically acceptable values measured for the CR laser was (5-36) mW and voltage range for PMT’s was (4-8) V. The light detection amplifier was investigated, and the optimal Laser Power and PMT gain used for scanning was measured. The tools that we used (CNR, MTF, NPS, DQE and Contrast-detail phantom) provided an effective means of selecting optimal values for the electro-optical components of the system. The procedure enabled us to obtain good quality CR mammograms that have less noise and improved contrast. Keywords: Computed Radiography, Mammography, Modulation Transfer Function, Noise Power Spectrum, Detective Quantum Efficiency, Photomultiplier tube, CDMAM 3.4 Phantom