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

FDA 510(k)

MAGNETOM TRIO SYSTEM

K-Number: K013586 · 2001-12-28

ApplicantSiemens Medical Systems, Inc.
Decision Date2001-12-28
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM TRIO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-12-28 under 510(k) number K013586. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNETOM TRIO SYSTEM?

MAGNETOM TRIO SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-28. The listed applicant is Siemens Medical Systems, Inc.. The 510(k) number is K013586.

When did MAGNETOM TRIO SYSTEM receive FDA 510(k) clearance?

MAGNETOM TRIO SYSTEM received FDA 510(k) clearance on 2001-12-28, under 510(k) number K013586.

Who is the listed applicant for MAGNETOM TRIO SYSTEM?

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

What is the FDA product code for MAGNETOM TRIO SYSTEM?

The FDA product code for MAGNETOM TRIO SYSTEM is LNH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Siemens Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123540SYNGO CT PULMO 3DK123541SYNGO.CT NEURO PERFUSIONK122909SYNGO SINGLE SOURCE DUAL ENGERYK122471SOMATOM DEFINITIONK120579SOMATOM DEFINITION EDGEK121072SOMATOM DEFINITION FLASH

View all 23 devices →

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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.

↑