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FDA 510(k)

HI-STAR MRI IMAGING SYSTEM

K-Number: K964778 · 1997-02-24

ApplicantHealth Images, Inc.
Decision Date1997-02-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HI-STAR MRI IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Health Images, Inc.. It received FDA 510(k) clearance on 1997-02-24 under 510(k) number K964778. 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 HI-STAR MRI IMAGING SYSTEM?

HI-STAR MRI IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-24. The listed applicant is Health Images, Inc.. The 510(k) number is K964778.

When did HI-STAR MRI IMAGING SYSTEM receive FDA 510(k) clearance?

HI-STAR MRI IMAGING SYSTEM received FDA 510(k) clearance on 1997-02-24, under 510(k) number K964778.

Who is the listed applicant for HI-STAR MRI IMAGING SYSTEM?

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

What is the FDA product code for HI-STAR MRI IMAGING SYSTEM?

The FDA product code for HI-STAR MRI IMAGING SYSTEM is LNH.

Related Clinical Trials

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Other records listing Health Images, 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.

K944724HEALTH IMAGE INC. HI STARK944228HEALTH IMAGES, INC. HI-STANDARDK911746H.I.STANDARD CALIBRE UPGRADEK890092HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE

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

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