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FDA 510(k)

MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM

K-Number: K894974 · 1989-09-12

ApplicantResonex, Inc.
Decision Date1989-09-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Resonex, Inc.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K894974. 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 MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM?

MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is Resonex, Inc.. The 510(k) number is K894974.

When did MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM receive FDA 510(k) clearance?

MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM received FDA 510(k) clearance on 1989-09-12, under 510(k) number K894974.

Who is the listed applicant for MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM?

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 MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM?

The FDA product code for MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM 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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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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