1. Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA (Corresponding author), e-mail: terry.woods@fda.hhs.gov, https://orcid.org/0000-0002-4584-2012
2. Center for Devices and Radiological Health, Office of In-Vitro Diagnostics and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA
3. Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA