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FDA 510(k)

3D TOF ANGIOGRAPHY MEASURING FUNCTION

K-Number: K920441 · 1992-07-30

ApplicantHitachi Medical Systems America, Inc.
Decision Date1992-07-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D TOF ANGIOGRAPHY MEASURING FUNCTION 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 1992-07-30 under 510(k) number K920441. 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 3D TOF ANGIOGRAPHY MEASURING FUNCTION?

3D TOF ANGIOGRAPHY MEASURING FUNCTION is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K920441.

When did 3D TOF ANGIOGRAPHY MEASURING FUNCTION receive FDA 510(k) clearance?

3D TOF ANGIOGRAPHY MEASURING FUNCTION received FDA 510(k) clearance on 1992-07-30, under 510(k) number K920441.

Who is the listed applicant for 3D TOF ANGIOGRAPHY MEASURING FUNCTION?

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 3D TOF ANGIOGRAPHY MEASURING FUNCTION?

The FDA product code for 3D TOF ANGIOGRAPHY MEASURING FUNCTION 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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