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FDA 510(k)

HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K-Number: K890092 · 1989-06-23

ApplicantHealth Images, Inc.
Decision Date1989-06-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE 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 1989-06-23 under 510(k) number K890092. 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 STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Health Images, Inc.. The 510(k) number is K890092.

When did HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE receive FDA 510(k) clearance?

HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE received FDA 510(k) clearance on 1989-06-23, under 510(k) number K890092.

Who is the listed applicant for HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

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 STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

The FDA product code for HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE 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.

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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.

K964778HI-STAR MRI IMAGING SYSTEMK944724HEALTH IMAGE INC. HI STARK944228HEALTH IMAGES, INC. HI-STANDARDK911746H.I.STANDARD CALIBRE UPGRADE

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.

K261283APERTO Lucent MRI SystemFujifilm CorporationK261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.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.,LtdK253808AIR 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.

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