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FDA 510(k)

ESTEEM 1.5T MRI SYSTEM

K-Number: K962677 · 1996-09-20

ApplicantElscint Mr, Inc.
Decision Date1996-09-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ESTEEM 1.5T MRI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint Mr, Inc.. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K962677. 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 ESTEEM 1.5T MRI SYSTEM?

ESTEEM 1.5T MRI SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Elscint Mr, Inc.. The 510(k) number is K962677.

When did ESTEEM 1.5T MRI SYSTEM receive FDA 510(k) clearance?

ESTEEM 1.5T MRI SYSTEM received FDA 510(k) clearance on 1996-09-20, under 510(k) number K962677.

Who is the listed applicant for ESTEEM 1.5T MRI SYSTEM?

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

What is the FDA product code for ESTEEM 1.5T MRI SYSTEM?

The FDA product code for ESTEEM 1.5T MRI SYSTEM 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 Elscint Mr, 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.

K972826ESTEEM 1.5T MRI SYSTEMK970990GYREX PRIMA 1TG 1.0T MRI SYSTEM

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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