K123622 Trade / Medical Solutions Inc. / Job Responsible Third Party Official Regulatory Technology Services LLC / EMC / Vitro Diagnostics / Ultrasound Group / Siemens Medical Solutions Inc. / Siemens Medical Solutions USA Inc. / Submission Siemens Medical Solutions Inc. / InVitro Diagnostics / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
resolution imaging format / Wireless Network / manufacturing practice requirements / manufacturing practice / imaging / energy / doppler imaging system / frequency imaging / announcements concerning your device / submission technology / tissue imaging / marketed predicate devices / submission device / contrast pulse sequencing technology / /
MedicalTreatment
catheters / /
Organization
Mark Job Responsible Third Party / Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / office of Compliance / Center for Devices / Center for Devices and Radiological Health / FDA / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Radiological Devices Office / /
Person
Silver Spring / NEMA UD / Patrick J. Lynch / Jeffrey Ballyns / / /
Position
physician / physician for clinical diagnosis purposes / Director Division / /
1ws6 22 Siemens Medical Solutions, Inc. Ultrasound Division SC2000 Ultrasound System 510(k) Submission