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FDA 510(k)

Velacur

K-Number: K223287 · 2023-04-20

ApplicantSonic Incytes
Decision Date2023-04-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Velacur is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Incytes. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K223287. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velacur?

Velacur is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Sonic Incytes. The 510(k) number is K223287.

When did Velacur receive FDA 510(k) clearance?

Velacur received FDA 510(k) clearance on 2023-04-20, under 510(k) number K223287.

Who is the listed applicant for Velacur?

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

What is the FDA product code for Velacur?

The FDA product code for Velacur is IYO.

Related Clinical Trials

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.

NCT04682600The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFFCOMPLETED

Other records listing Sonic Incytes 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.

K233977VelacurK232459VelacurK201597Liver Incytes, Model 1005

Related Devices (Code: IYO)

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.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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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