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FDA 510(k)

COILS FOR RX4000 & RX5000 MRI SYSTEMS

K-Number: K920254 · 1992-06-22

ApplicantResonex, Inc.
Decision Date1992-06-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COILS FOR RX4000 & RX5000 MRI SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Resonex, Inc.. It received FDA 510(k) clearance on 1992-06-22 under 510(k) number K920254. 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 COILS FOR RX4000 & RX5000 MRI SYSTEMS?

COILS FOR RX4000 & RX5000 MRI SYSTEMS is a medical device that received FDA 510(k) clearance on 1992-06-22. The listed applicant is Resonex, Inc.. The 510(k) number is K920254.

When did COILS FOR RX4000 & RX5000 MRI SYSTEMS receive FDA 510(k) clearance?

COILS FOR RX4000 & RX5000 MRI SYSTEMS received FDA 510(k) clearance on 1992-06-22, under 510(k) number K920254.

Who is the listed applicant for COILS FOR RX4000 & RX5000 MRI SYSTEMS?

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

What is the FDA product code for COILS FOR RX4000 & RX5000 MRI SYSTEMS?

The FDA product code for COILS FOR RX4000 & RX5000 MRI SYSTEMS is LNH.

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Other records listing Resonex, 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.

K935369FAST SPIN ECHO (FSE)K935570NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEMK931392ECG GATING UNITK9238703DTOF MRAK924154KINEMATIC MRI MOVIEMAKERK9238233D IMAGING

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Related Devices (Code: LNH)

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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

View on FDA Database →

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

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