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FDA 510(k)

2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)

K-Number: K914114 · 1991-12-04

ApplicantResonex, Inc.
Decision Date1991-12-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) is the device name listed in this FDA 510(k) record. The listed applicant is Resonex, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K914114. 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 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)?

2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Resonex, Inc.. The 510(k) number is K914114.

When did 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) receive FDA 510(k) clearance?

2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) received FDA 510(k) clearance on 1991-12-04, under 510(k) number K914114.

Who is the listed applicant for 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)?

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 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)?

The FDA product code for 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) 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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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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