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FDA 510(k)

MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)

K-Number: K914019 · 1991-11-01

ApplicantHitachi Medical Systems America, Inc.
Decision Date1991-11-01
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) 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 1991-11-01 under 510(k) number K914019. 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 MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)?

MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K914019.

When did MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) receive FDA 510(k) clearance?

MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) received FDA 510(k) clearance on 1991-11-01, under 510(k) number K914019.

Who is the listed applicant for MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)?

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 MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)?

The FDA product code for MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) 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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