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FDA 510(k)

Viz ICH

K-Number: K210209 · 2021-03-23

ApplicantViz. Ai, Inc.
Decision Date2021-03-23
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Viz ICH is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K210209. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viz ICH?

Viz ICH is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K210209.

When did Viz ICH receive FDA 510(k) clearance?

Viz ICH received FDA 510(k) clearance on 2021-03-23, under 510(k) number K210209.

Who is the listed applicant for Viz ICH?

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

What is the FDA product code for Viz ICH?

The FDA product code for Viz ICH is QAS.

Other records listing Viz. Ai, 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.

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Related Devices (Code: QAS)

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.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.

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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