1TR110601 Rev 01 DV Report Dated November 11, 2011 (Data on file)
2PPQ Report: TR-20009 Rev 01 dated March 9, 2015 (Data on File)
3AA study report: TR-20003 Rev 01 dated March 18, 2015 (Data on file)
4510k study TR100509 Rev 01 dated September 21, 2010 (Data on file).
5AA study TR100706 Rev 01 dated January 6, 2011 (Data on file).
6AA study TR110716 Rev 01 dated December 16, 2011 (Data on file).
7DV/PPQ report: TR110601 Rev 01 dated November 11, 2011 (Data on file).
8Based on internal testing data,V-0450-02 (Access DVT Report) dated February 8, 2019 (Data on file).
9Internal test report #1085, July 8, 2014 and Internal test report #1090, September 25, 2014 (Data on file).
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14Kothari S, Kothari T, et al. 234, Endoscopic Ultrasound (EUS)-Guided Fiducial Placement for Stereotactic Body Radiotherapy (SBRT): First Global Experience with a New 22-Gauge “Pre-loaded” EUS Fiducial Needle The American Journal of Gastroenterology, vol 110, Supplement 1 October 2015
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17Vogl et al. (2017). Evaluation of microwave ablation of liver malignancy with enabled constant spatial energy control to achieve a predictable spherical ablation zone. International Journal of Hyperthermia, DOI: 10.1080/02656736.2017.1358408.
18Imajo K. et al. New microwave ablation system for unresectable liver tumors that forms large, spherical ablation zones. J Gastroenterol Hepatol. 2018;33(12):2007-2014.
19Vogl, TJ., Basten, LM., Nour-Eldin, A., Kaltenbach, B., Bodelle, B., Wichmann, JL., Ackermann, H., Naguib, NNN. Evaluation of microwave ablation of liver malignancy with enabled constant spatial energy control to achieve a predictable spherical ablation zones. Int J Hyperthermia. 2018 Jun;34(4):492-500.
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