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)

MAGNAVIEW MOBILE MRI VERSION 110 FHM

K-Number: K891543 · 1989-06-23

ApplicantInstrumentarium Imaging, Inc.
Decision Date1989-06-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNAVIEW MOBILE MRI VERSION 110 FHM is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Imaging, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K891543. 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 MAGNAVIEW MOBILE MRI VERSION 110 FHM?

MAGNAVIEW MOBILE MRI VERSION 110 FHM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K891543.

When did MAGNAVIEW MOBILE MRI VERSION 110 FHM receive FDA 510(k) clearance?

MAGNAVIEW MOBILE MRI VERSION 110 FHM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K891543.

Who is the listed applicant for MAGNAVIEW MOBILE MRI VERSION 110 FHM?

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

What is the FDA product code for MAGNAVIEW MOBILE MRI VERSION 110 FHM?

The FDA product code for MAGNAVIEW MOBILE MRI VERSION 110 FHM 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 Instrumentarium Imaging, 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.

K002472DELTA 32 AND DELTA 32 TACTK001928SIGMAK000976DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)K001171DELTA 16 TACTK973642ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100K955411DELTA 16

View all 24 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.

↑