Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

syngo. CT Single Source Dual Energy (twin beam)

K-Number: K163289 · 2017-02-09

ApplicantSiemens Medical Solutions USA, Inc., Ultrasound DI
Decision Date2017-02-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K163289.

When was syngo. CT Single Source Dual Energy (twin beam) approved by the FDA?

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

What company makes syngo. CT Single Source Dual Energy (twin beam)?

syngo. CT Single Source Dual Energy (twin beam) is manufactured by Siemens Medical Solutions USA, Inc., Ultrasound DI.

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.

Related Clinical Trials

NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT07592533 A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT06377007 Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) COMPLETED NCT04963205 Sleeping Position Study in COPD Patients COMPLETED NCT04559685 Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma TERMINATED

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑