FDA 510(k)

IMIG-MRI

K-Number: K963953 · 1996-12-18

Decision Date1996-12-18

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IMIG-MRI is the device name listed in this FDA 510(k) record. The listed applicant is Imig-Mri Systems, LLC. It received FDA 510(k) clearance on 1996-12-18 under 510(k) number K963953. 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 IMIG-MRI?

IMIG-MRI is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Imig-Mri Systems, LLC. The 510(k) number is K963953.

When did IMIG-MRI receive FDA 510(k) clearance?

IMIG-MRI received FDA 510(k) clearance on 1996-12-18, under 510(k) number K963953.

Who is the listed applicant for IMIG-MRI?

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

What is the FDA product code for IMIG-MRI?

The FDA product code for IMIG-MRI is LNH.

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 Corporation K260758MAGNETOM 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.,Ltd K253808AIR Recon DLGE Medical Systems

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.