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FDA 510(k)

Uscan

K-Number: K181574 · 2018-07-10

ApplicantEchoNous, Inc.
Decision Date2018-07-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Uscan is the device name listed in this FDA 510(k) record. The listed applicant is EchoNous, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K181574. 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 Uscan?

Uscan is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is EchoNous, Inc.. The 510(k) number is K181574.

When did Uscan receive FDA 510(k) clearance?

Uscan received FDA 510(k) clearance on 2018-07-10, under 510(k) number K181574.

Who is the listed applicant for Uscan?

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

What is the FDA product code for Uscan?

The FDA product code for Uscan 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.

NCT07771231Kosmos PLAX EF Pivotal StudyACTIVE_NOT_RECRUITINGNCT07771270Kosmos Guidance Performance Evaluation Data AnnotationACTIVE_NOT_RECRUITING

Other records listing EchoNous, 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.

K242321KosmosK233826KosmosK212100KosmosK193518KOSMOS

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

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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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