K123610 Trade / Radiological Hafti / Per 21 CFR0109 Offbeof InVitro Diagnostics / In Vitro Diagnostics / ALPINION MEDICAL SYSTEMS Co. Ltd. / CUBE 9 Diagnostic Ultrasound System ALPINION MEDICAL SYSTEMS Co. Ltd. / ALPIhJION MEDICAL SYSTEMS Co. Ltd. / E-CUBE 15 / /
Country
South Korea / / /
Event
FDA Phase / /
Facility
Avenue Docment Control Center / Verti Tower / Verdi Tower / / /
IndustryTerm
ultrasound imaging / clinical applications / announcements concerning your device / pulsed doppler imaging system / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / imaging / fundamental scientific technology / ultrasound imaging system / /
OperatingSystem
L3 / /
Organization
Radiological Health Office / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / CDRH 's office of Surveillance / FDA / Radiological Health Center for Devices / DEPARTMENT OF HEALTH / /
Person
Donghwan Kim / Janine M. Morris / Cardiac Pediatric Intravascular / Abdominal Intra-operative (Specify) / Joshua Nipper / / /
Position
Director / Division / qualified physician / QARA Manager / Manager Address / /
Product
Olympus E-3 Digital Camera / SVCI-6 / /
ProgrammingLanguage
E / R / C / /
ProvinceOrState
Maryland / Washington / /
Technology
radiation / Ultrasound / same fundamental scientific technology / Ultrasound System / /
FSB[removed]k) E-CUBE[removed]k)iSummary In accordance with 21CFR807.92, the following summary of information is provided;