K-number	K242321
Device name	Kosmos
Applicant	EchoNous, Inc.
Product code	IYN
Device class	Class II
Decision date	Apr 25, 2025
Decision	Substantially Equivalent
Regulation	892.1550

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Kosmos is a portable ultrasound imaging system running on Android that acquires, processes, displays, measures, and stores ultrasound images. It is intended for use by qualified healthcare professionals to assess the cardiac, pulmonary, and abdominal systems in adult and pediatric patients in clinical care and medical education settings.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Kosmos

Everything you need for a 510(k) submission. Nothing you don't.