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FDA 510(k)

VERSION 3.7 OPERATING SYSTEM SOFTWARE

K-Number: K960181 · 1996-03-05

ApplicantHitachi Medical Systems America, Inc.
Decision Date1996-03-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERSION 3.7 OPERATING SYSTEM SOFTWARE 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 1996-03-05 under 510(k) number K960181. 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 VERSION 3.7 OPERATING SYSTEM SOFTWARE?

VERSION 3.7 OPERATING SYSTEM SOFTWARE is a medical device that received FDA 510(k) clearance on 1996-03-05. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K960181.

When did VERSION 3.7 OPERATING SYSTEM SOFTWARE receive FDA 510(k) clearance?

VERSION 3.7 OPERATING SYSTEM SOFTWARE received FDA 510(k) clearance on 1996-03-05, under 510(k) number K960181.

Who is the listed applicant for VERSION 3.7 OPERATING SYSTEM SOFTWARE?

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 VERSION 3.7 OPERATING SYSTEM SOFTWARE?

The FDA product code for VERSION 3.7 OPERATING SYSTEM SOFTWARE 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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