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FDA 510(k)

MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION

K-Number: K911642 · 1991-05-30

ApplicantHitachi Medical Systems America, Inc.
Decision Date1991-05-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION 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 1991-05-30 under 510(k) number K911642. 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 AND MRP-7000 MULTIPLANAR RECONSTRUCTION?

MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K911642.

When did MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION receive FDA 510(k) clearance?

MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION received FDA 510(k) clearance on 1991-05-30, under 510(k) number K911642.

Who is the listed applicant for MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION?

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 AND MRP-7000 MULTIPLANAR RECONSTRUCTION?

The FDA product code for MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION is 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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