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FDA 510(k)

Kosmos

K-Number: K242321 · 2025-04-25

ApplicantEchoNous, Inc.
Decision Date2025-04-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kosmos is the device name listed in this FDA 510(k) record. The listed applicant is EchoNous, Inc.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K242321. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kosmos?

Kosmos is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is EchoNous, Inc.. The 510(k) number is K242321.

When did Kosmos receive FDA 510(k) clearance?

Kosmos received FDA 510(k) clearance on 2025-04-25, under 510(k) number K242321.

Who is the listed applicant for Kosmos?

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 Kosmos?

The FDA product code for Kosmos is IYN.

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.

K233826KosmosK212100KosmosK193518KOSMOSK181574Uscan

Related Devices (Code: IYN)

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.

K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLCK261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care DiagnosticsK261288Handheld Ultrasound ScannerIMGFAX CO., LTD.K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;Samsung Medison Co., Ltd.K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC

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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