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FDA 510(k)

Viz SDH

K-Number: K220439 · 2022-07-25

ApplicantViz. Ai, Inc.
Decision Date2022-07-25
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Viz SDH 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 2022-07-25 under 510(k) number K220439. 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 SDH?

Viz SDH is a medical device that received FDA 510(k) clearance on 2022-07-25. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K220439.

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

Viz SDH received FDA 510(k) clearance on 2022-07-25, under 510(k) number K220439.

Who is the listed applicant for Viz SDH?

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 SDH?

The FDA product code for Viz SDH 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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