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FDA 510(k)

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis

K-Number: K173637 · 2018-03-30

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-03-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2018-03-30 under approval number K173637. 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 Coronary Analysis; syngo.CT Vascular Analysis?

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K173637.

When was syngo.CT Coronary Analysis; syngo.CT Vascular Analysis approved by the FDA?

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis received FDA 510(k) clearance on 2018-03-30, under approval number K173637.

What company makes syngo.CT Coronary Analysis; syngo.CT Vascular Analysis?

syngo.CT Coronary Analysis; syngo.CT Vascular Analysis is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.CT Coronary Analysis; syngo.CT Vascular Analysis?

The FDA product code for syngo.CT Coronary Analysis; syngo.CT Vascular Analysis is JAK.

Related Clinical Trials

NCT02890160 A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II COMPLETED NCT07510438 AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease RECRUITING NCT04772911 Multicenter Phenotype-Genotype Analysis of Vascular Stains to Optimize Treatment Utilizing Optical Coherence Tomography ACTIVE_NOT_RECRUITING NCT07586683 OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia NOT_YET_RECRUITING NCT07586241 Vascular Endothelial Inflammation and Health Status In INOCA (VISION-INOCA) NOT_YET_RECRUITING NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING

Related PubMed Literature

PMID: 25366498 Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments. BMC cardiovascular disorders (2014)

Other Devices by Siemens Medical Solutions USA, Inc.

K162302Somatom Confidence ® RT Pro K162971Multix Fusion Max K161795MAGNETOM ESSENZA K162541syngo Application Software K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162370syngo.via RT Image Suite

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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.

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