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FDA 510(k)

HEALTH IMAGES, INC. HI-STANDARD

K-Number: K944228 · 1995-07-20

ApplicantHealth Images, Inc.
Decision Date1995-07-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEALTH IMAGES, INC. HI-STANDARD 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 1995-07-20 under 510(k) number K944228. 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 HEALTH IMAGES, INC. HI-STANDARD?

HEALTH IMAGES, INC. HI-STANDARD is a medical device that received FDA 510(k) clearance on 1995-07-20. The listed applicant is Health Images, Inc.. The 510(k) number is K944228.

When did HEALTH IMAGES, INC. HI-STANDARD receive FDA 510(k) clearance?

HEALTH IMAGES, INC. HI-STANDARD received FDA 510(k) clearance on 1995-07-20, under 510(k) number K944228.

Who is the listed applicant for HEALTH IMAGES, INC. HI-STANDARD?

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 HEALTH IMAGES, INC. HI-STANDARD?

The FDA product code for HEALTH IMAGES, INC. HI-STANDARD 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 STARK911746H.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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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