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FDA 510(k)

MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K-Number: K942560 · 1994-09-09

ApplicantHitachi Medical Systems America, Inc.
Decision Date1994-09-09
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETIC RESONANCE DIAGNOSTIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K942560. 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 MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

MAGNETIC RESONANCE DIAGNOSTIC DEVICE is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K942560.

When did MAGNETIC RESONANCE DIAGNOSTIC DEVICE receive FDA 510(k) clearance?

MAGNETIC RESONANCE DIAGNOSTIC DEVICE received FDA 510(k) clearance on 1994-09-09, under 510(k) number K942560.

Who is the listed applicant for MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

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

What is the FDA product code for MAGNETIC RESONANCE DIAGNOSTIC DEVICE?

The FDA product code for MAGNETIC RESONANCE DIAGNOSTIC DEVICE is LNH.

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Other records listing Hitachi Medical Systems America, 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.

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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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