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FDA 510(k)

Liver Incytes, Model 1005

K-Number: K201597 · 2020-07-31

ApplicantSonic Incytes
Decision Date2020-07-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Liver Incytes, Model 1005 is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Incytes. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201597. 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 Liver Incytes, Model 1005?

Liver Incytes, Model 1005 is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Sonic Incytes. The 510(k) number is K201597.

When did Liver Incytes, Model 1005 receive FDA 510(k) clearance?

Liver Incytes, Model 1005 received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201597.

Who is the listed applicant for Liver Incytes, Model 1005?

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 Liver Incytes, Model 1005?

The FDA product code for Liver Incytes, Model 1005 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.

K233977VelacurK232459VelacurK223287Velacur

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.

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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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