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FDA 510(k)

AIRIS

K-Number: K945155 · 1995-05-24

ApplicantHitachi Medical Systems America, Inc.
Decision Date1995-05-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIRIS 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 1995-05-24 under 510(k) number K945155. 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 AIRIS?

AIRIS is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K945155.

When did AIRIS receive FDA 510(k) clearance?

AIRIS received FDA 510(k) clearance on 1995-05-24, under 510(k) number K945155.

Who is the listed applicant for AIRIS?

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 AIRIS?

The FDA product code for AIRIS 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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Related Devices (Code: 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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