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FDA-cleared K233826

Kosmos

EchoNous, Inc.

Kosmos acquires, processes, displays, measures, and stores ultrasound with synchronized ECG and digital auscultation across cardiac, lung, abdominal, vascular, musculoskeletal, and interventional applications. Adult-only Auto EF and AI FAST are adjunct functions.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2024-08-29
FDA-cleared K212100

Kosmos

EchoNous, Inc.

Authorized purpose: Kosmos is tablet-based ultrasound for adult and pediatric cardiac, lung, abdominal, vascular, musculoskeletal, and procedure-guidance applications; Torso configurations can include ECG and digital auscultation.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2021-08-06
FDA-cleared K193518

KOSMOS

EchoNous, Inc.

Authorized purpose: KOSMOS combines general-purpose ultrasound with synchronized three-lead single-channel ECG and digital auscultation for adult and pediatric cardiac, lung, abdominal, vascular, and procedure-guidance assessment in clinical care and medical education.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2020-03-26
FDA-cleared K181574

Uscan

EchoNous, Inc.

Authorized purpose: Uscan is a diagnostic ultrasound system for abdominal, musculoskeletal, pediatric, small-organ, and peripheral-vessel imaging by trained users.

Modality
Ultrasound
Anatomy
Multi-region
Decision
2018-07-10