1. Division of Radiological Health Center for Devices and Radiological Health US Food and Drug Administration 10903 New Hampshire, Ave WO66‐Rm 4236 Silver Spring MD 20993USA
2. Office of In Vitro Devices and Radiological Health Center for Devices and Radiological Health, US Food and Drug Administration 10903 New Hampshire, Ave WO66-Rm 4236 Silver Spring MD 20993USA