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FDA 510(k)

MAGNETIC RESONANCE DIAGNOSTIC DEVICE

K-Number: K923010 · 1992-08-25

ApplicantHitachi Medical Systems America, Inc.
Decision Date1992-08-25
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 1992-08-25 under 510(k) number K923010. 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 1992-08-25. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K923010.

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

MAGNETIC RESONANCE DIAGNOSTIC DEVICE received FDA 510(k) clearance on 1992-08-25, under 510(k) number K923010.

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

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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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