[i]Discovery MI is 510(k) pending at FDA. Not available for sale in the United States. Not yet CE marked. Cannot be placed on the market or put into service until it has been made to comply with CE Marking or otherwise obtained all required regulatory authorizations.

[ii]Improved detectability as demonstrated in phantom testing.


[iii]In clinical practice, the use of Discovery NM/CT 670 CZT may improve quantification of lesions larger than 5.5mL, 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 or scan time to obtain the claimed quantification accuracy for the particular clinical task.

[iv]In clinical practice, the use of Discovery NM/CT 670 CZT may improve lesions detectability 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 or scan time to obtain diagnostic image quality for the particular clinical task.

[v]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 measured in 0.625 mm slices and tested for both head and body modes using the MITA CT IQ Phantom (CCT183, The Phantom Laboratory), using model observer method.

[vi]Together with Evolution technology*.
*In clinical practice, Evolution options6a (Evolution for Bone, Evolution for Cardiac, Evolution for Bone Planar) and Evolution Toolkit6b 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.

6aEvolution 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.

6bEvolution 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 compare to the images reconstructed with FBP / OSEM.

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