1. 510(k) K172404.
2. Data on file. GE HealthCare 2017.
3. Over 8 hours. Data on file, GE HealthCare 2019.
4. Andrew Mosier DO, Esha Gupta MD, Dana Ataya MD, Kavita Bhatt MD, Alice Rim MD.
March 2017. https//doi.org/10.1111/tbj.12784.
5. Phillips et al. Workflow Considerations for Incorporation of Contrast-Enhanced Spectral
Mammography Into a Breast Imaging Practice, ACR, 2018 https://doi.org/10.1016/
j.jacr.2018.02.0121.
6. Compared to without contrast.
7. J. Sung et al., Radiology 2019; 00:1-8.
8. V. Sorin et al. American Journal of Roentgenology: W267-W274. 10.2214/
AJR.17.1935510(k) K172404.
9. 510(k) K211215. Reader study performed by 3 MQSA qualified radiologists on 50 clinical
images, comparing SenoBright HD with NIRA to current version.
* Superior diagnostic accuracy demonstrated in a reader study comparing the ROC AUC of GE screening protocol (V-Preview + 3D CC/MLO with 3D in STD mode) to that of 2D FFDM alone. V-Preview is the 2D synthesized image generated by GE Seno Iris mammography software from GE DBT images. FDA PMA P130020 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130020.
** As compared to Pristina Serena 2D biopsy. Data on file GE HealthCare 2018.