Radiological Health Siemens Medical Solutions USA Inc. / Job Responsible Third Party Official Regulatory Technology Services LLC / Siemens Medical Solutions USA Inc. / K121807 Trade / Submission Siemens Medical Solutions USA Inc. / Siemens / /
Currency
pence / /
Event
FDA Phase / /
IndustryTerm
understood tool / 0V70 ultrasound imaging system / cardiology applications / manufacturing practice requirements / ultrasound imaging systems / ultrasound energy / marketed predicate devices / manufacturing practice / ffirther announcements concerning your device / ultrasound imaging system / submission device / /
Mark Job Responsible Third Party / Division of Postmarket Surveillance / HUMAN SERVICES Public Health Service / American Association of Echocardiography / Submission American Association of Echocardiography / Society for Vascular Imaging / Center for Devices and Radiological Health / office of Compliance / FDA / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Drug Administration / Carotid Intima-Media Thickness Task Force / Center for Devices / Radiological Devices Office / /
Person
M. Morris Acting / Janine M. Morris / Shelly Pearce / Lauren Hefnier / / /
Position
Acting Director Division / physician / physician for clinical diagnosis purposes. f / physician for clinical diagnosis purposes / Regulatory Affairs Specialist / Director Division / /
Siemens Medical Solutions USA, Inc. Ultrasound Division V5Ms Transesophageal Transducer Special 510(k) Submission