FDA 510(k)

ViewPoint 6

K-Number: K173456 · 2018-01-05

ApplicantGe Medical Systems Ultrasound and Primary

Decision Date2018-01-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ViewPoint 6 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K173456. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViewPoint 6?

ViewPoint 6 is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Ge Medical Systems Ultrasound and Primary. The 510(k) number is K173456.

When did ViewPoint 6 receive FDA 510(k) clearance?

ViewPoint 6 received FDA 510(k) clearance on 2018-01-05, under 510(k) number K173456.

Who is the listed applicant for ViewPoint 6?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewPoint 6?

The FDA product code for ViewPoint 6 is LLZ.

Related Devices (Code: LLZ)

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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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.