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FDA 510(k)

Voyant System

K-Number: K191579 · 2019-07-11

ApplicantViseon, Inc.
Decision Date2019-07-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Voyant System is the device name listed in this FDA 510(k) record. The listed applicant is Viseon, Inc.. It received FDA 510(k) clearance on 2019-07-11 under 510(k) number K191579. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voyant System?

Voyant System is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is Viseon, Inc.. The 510(k) number is K191579.

When did Voyant System receive FDA 510(k) clearance?

Voyant System received FDA 510(k) clearance on 2019-07-11, under 510(k) number K191579.

Who is the listed applicant for Voyant System?

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

What is the FDA product code for Voyant System?

The FDA product code for Voyant System is HRX.

Other records listing Viseon, 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.

K181885Voyant System

Related Devices (Code: HRX)

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.

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