FDA 510(k)

HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER

K-Number: K102901 · 2010-10-27

ApplicantHitachi Medical Systems America, Inc.

Decision Date2010-10-27

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER 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 2010-10-27 under 510(k) number K102901. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER?

HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 2010-10-27. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K102901.

When did HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER receive FDA 510(k) clearance?

HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER received FDA 510(k) clearance on 2010-10-27, under 510(k) number K102901.

Who is the listed applicant for HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER?

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 HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER?

The FDA product code for HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.