Aurora

1. Aurora and Clarify DL as part of Xeleris V are CE marked. Aurora is not approved or cleared by the U.S. FDA. Clarify DL is 510(k) pending at the U.S. FDA. Not available for sale in the United States.
2. Using overlapped reconstruction
3. The statement by the GE HealthCare customer described here is based on their own opinions and experiences and on results that were achieved in the customer’s unique setting. Since there is no typical hospital and many variables exist, such as hospital size, case mix, etc., there can be no guarantee that other customers will achieve the same results.
4. Clarify DL improves contrast recovery coefficient (CRC) up to 82% and contrast to noise ratio (CNR) up to 58% as compared to use of GE bone SPECT factory reconstruction presets for dual head cameras.* CRC and CNR are important factors in lesion detectability. *CRC and CNR demonstrated using digital phantom with inserted lesions of known size, location, and contrast, for AC and NC images.
5. Clarify DL improves dual head cameras’ image quality performance measured by Structures Similarity (SSIM) – up to 8% improvement, Mean Squared Error (MSE) up to 76% improvement, and Peak Signal-to-Noise Ratio (PSNR) - up to 18% improvement, as compared to GE bone SPECT factory reconstruction presets*. Improved image quality performance may help increase diagnostic confidence. *Demonstrated using digital phantom simulations with inserted lesions of known size, location, and contrast, for AC and NC images.
6. In 127 exams rated by total of 9 physicians, in 98% of the exams, Clarify DL’s image resolution was rated as better than the existing factory reconstruction preset images.* *As demonstrated in clinical evaluation, where each exam was reconstructed with both Clarify DL and the existing factory reconstruction preset and evaluated by 3 of the physicians.
7. Compared to LEHR collimator, with Step & Shoot scan mode (for SPECT). As demonstrated in phantom testing using a bone scan protocol, Evolution processing (for SPECT), and a model observer. Because model observer results may not always match those from a human reader, the actual time/dose reduction depends on the clinical task, patient size, anatomical location and clinical practice. A radiologist should determine the appropriate scan time/dose for the particular clinical task.
8. As demonstrated in phantom testing using a model observer. Compared to using the LEHR Collimator and a SPECT Step and Shoot acquisition.
9. In clinical practice, Evolution Options [9a] (Evolution for Bone, Evolution for Cardiac, Evolution for Bone Planar) and Evolution Toolkit [9b] are recommended for use following consultation of a Nuclear Medicine physician, physicist and/or application specialist to determine the appropriate dose or scan time reduction to obtain diagnostic image quality for a particular clinical task, depending on the protocol adopted by the clinical site.
9a. Evolution Options–Evolution claims are supported by simulation of count statistics using default factory protocols and imaging of 99mTc based radiotracers with LEHR collimator on anthropomorphic phantom or realistic NCAT–SIMSET phantom followed by quantitative and qualitative images comparison.
9b. Evolution Toolkit–Evolution Toolkit claims are supported by simulation of full count statistics using lesion simulation phantom images based on various radiotracers and collimators and by showing that SPECT image quality reconstructed with Evolution Toolkit provide equivalent clinical information but have better signal-to-noise, contrast, and lesion resolution compared to the images reconstructed with FBP/OSEM.
10a. ASiR-V reduces dose by 50% to 82% relative to FBP at the same image quality (Image quality as defined by low contrast detectability.)
10b. In clinical practice, the use of ASiR‐V may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. Low Contrast Detectability (LCD), Image Noise, Spatial Resolution and Artifact were assessed using reference factory protocols comparing ASiR‐V and FBP. The LCD was measured using 0.625 mm slices and tested for both head and body modes using the MITA CT IQ Phantom (CCT183, The Phantom Laboratory), using a model observer method.
11. As compared to NM/CT 870 DR with Optima 540 CT.
12. 0.35 rotation speed is optional. 0.5 second rotation speed is standard.
13. This is demonstrated in cardiac phantom testing. The reduction in motion artifacts is comparable to a 0.058s Equivalent Gantry Rotation Speed with effective temporal resolution of 29 msec, as demonstrated in mathematical phantom testing.
14. The image quality for the area outside the standard 50 cm scan field does not meet the image quality specifications shown in the technical data sheet and image artifacts may appear, depending on the anatomy scanned.
15. Compared to NM/CT 870 DR