FDA 510(k)

syngo. CT Single Source Dual Energy (twin beam)

N.º K: K163289 · 2017-02-09

SolicitanteSiemens Medical Solutions USA, Inc., Ultrasound DI

Fecha de decisión2017-02-09

Código de productoJAK

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

syngo. CT Single Source Dual Energy (twin beam) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K163289. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the syngo. CT Single Source Dual Energy (twin beam)?

syngo. CT Single Source Dual Energy (twin beam) is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K163289.

When did syngo. CT Single Source Dual Energy (twin beam) receive FDA 510(k) clearance?

syngo. CT Single Source Dual Energy (twin beam) received FDA 510(k) clearance on 2017-02-09, under 510(k) number K163289.

Who is the listed applicant for syngo. CT Single Source Dual Energy (twin beam)?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc., Ultrasound DI as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo. CT Single Source Dual Energy (twin beam)?

The FDA product code for syngo. CT Single Source Dual Energy (twin beam) is JAK.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.