FDA 510(k)

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS

K-Number: K153421 · 2016-01-21

ApplicantHitachi Aloka Medical America, Inc.

Decision Date2016-01-21

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Aloka Medical America, Inc.. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153421. 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 ASCENDUS, HV ASCENDUS, ASCENDUS?

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Hitachi Aloka Medical America, Inc.. The 510(k) number is K153421.

When did HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS receive FDA 510(k) clearance?

HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153421.

Who is the listed applicant for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

The FDA 510(k) record lists Hitachi Aloka Medical America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?

The FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is IYN.

Other records listing Hitachi Aloka Medical 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.

K152126UST-5550-R; UST-5536-R; L43K

Related Devices (Code: IYN)

Official Source

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