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)

MRI ULTRAVIEW

K-Number: K915260 · 1992-03-16

ApplicantA&E Specialty Fabricators
Decision Date1992-03-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRI ULTRAVIEW is the device name listed in this FDA 510(k) record. The listed applicant is A&E Specialty Fabricators. It received FDA 510(k) clearance on 1992-03-16 under 510(k) number K915260. 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 MRI ULTRAVIEW?

MRI ULTRAVIEW is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is A&E Specialty Fabricators. The 510(k) number is K915260.

When did MRI ULTRAVIEW receive FDA 510(k) clearance?

MRI ULTRAVIEW received FDA 510(k) clearance on 1992-03-16, under 510(k) number K915260.

Who is the listed applicant for MRI ULTRAVIEW?

The FDA 510(k) record lists A&E Specialty Fabricators as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRI ULTRAVIEW?

The FDA product code for MRI ULTRAVIEW 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

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.

↑