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.MR General, syngo.MR Cardiology, syngo.MR Neurology

K-Number: K163294 · 2017-02-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-02-06 under approval number K163294. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology?

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology is a medical device that received FDA 510(k) clearance on 2017-02-06. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K163294.

When was syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology approved by the FDA?

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology received FDA 510(k) clearance on 2017-02-06, under approval number K163294.

What company makes syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology?

syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology?

The FDA product code for syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology is LLZ.

Related Clinical Trials

NCT02304029 Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy COMPLETED NCT07337577 Large Language Model-Generated Messages to Improve Guideline-Directed Medical Therapy in Heart Failure NOT_YET_RECRUITING

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

View all 248 devices →

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑