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)

1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT

K-Number: K121676 · 2012-09-20

ApplicantGe Medical Systems, LLC
Decision Date2012-09-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2012-09-20 under 510(k) number K121676. 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 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT?

1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K121676.

When did 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT receive FDA 510(k) clearance?

1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT received FDA 510(k) clearance on 2012-09-20, under 510(k) number K121676.

Who is the listed applicant for 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT?

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

What is the FDA product code for 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT?

The FDA product code for 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT 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 Ge Medical Systems, LLC 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.

K253560Enhanced Boundary for PCCTK253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmK253520Photonova Spectra, Photonova Spectra SelectK253780SIGNA™ BoltK253779SIGNA™ Sprint SelectK252379AIR Recon DL

View all 92 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.

↑