Class 11 90JAK Siemens Medical Solutions Inc. / In Vitro Diagnostics / Siemens Medical Solutions Inc. / Siemens Medical Solutions USA Inc. / K123541 Trade / Usability Siemens Medical Solutions Inc. / Regulatory Affairs Submissions Siemens Medical Solutions Inc. / /
Country
United States / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
software processes images / extraction product / announcements concerning your device / predicate devices / flow extraction product / predicate device / manufacturing practice requirements / contrast media / software specifications / post processing software package / simultaneous multi-slice processing / risk management / manufacturing practice / electrical equipment / software package / imaging / Internet address http /
Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / FDA / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Radiological Health Center for Devices and Radiological Health Indications for Use / CDRH's office of Surveillance / /
Person
Silver Spring / Janine M. Morris / Kimberly Mangum / / /
Position
Director / Division / General / Technical Specialist / /
Product
Federal Food / K073238 / 2I1CFR / /
ProvinceOrState
Pennsylvania / Maryland / /
Technology
radiation / X-ray System / Tomography / Digital Imaging / /