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Kosmos

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193518

by EchoNous, Inc.

Identifiers

510(k) Number
K193518 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kosmos is a Point-of-Care Ultrasound (POCUS) device designed for real-time diagnostic imaging at the bedside. It integrates artificial intelligence to enhance image acquisition, analysis, and interpretation, supporting clinical decision-making in radiology applications. The device combines cart-based imaging quality with handheld portability, enabling flexible use across diverse clinical settings. Its AI capabilities assist in guiding probe positioning and optimizing image clarity for improved diagnostic confidence.

Kosmos is supplied as a reusable medical device, intended for use in MRI-safe environments (as per manufacturer specifications). It is regulated under FDA 510(k) clearance (K193518) and MDR compliance, with a product code classification of IYN under the Radiology advisory committee. The device requires proper storage and maintenance per manufacturer guidelines to ensure performance integrity, though specific sterility or single-use details are not provided in the data.

Frequently asked questions

How does the Kosmos device combine portability with imaging quality, and what clinical settings would benefit most from its design?

The Kosmos integrates handheld portability with cart-based imaging quality, allowing clinicians to perform real-time ultrasound imaging at the bedside while maintaining high-resolution output. This design is particularly useful in acute care settings like emergency departments, intensive care units, and operating rooms, where mobility and quick diagnostic access are critical. Its flexibility supports radiology applications across diverse environments without sacrificing image clarity.

Is the Kosmos device intended for single-use or reusable applications, and what maintenance requirements should be considered?

The Kosmos is explicitly designed as a reusable medical device, requiring adherence to manufacturer-provided storage and maintenance protocols to preserve performance. Since it is not described as sterile or single-use, facilities must follow cleaning and servicing guidelines to ensure long-term reliability, especially in MRI-safe environments as specified by the manufacturer.

What regulatory pathways does the Kosmos follow, and how does its classification under the Radiology advisory committee influence its use?

The Kosmos is cleared via FDA 510(k) (K193518) under the Radiology (IYN) product code, with a substantially equivalent determination by the Radiology (RA) advisory committee. This classification ensures compliance with U.S. regulations while enabling its use in radiology applications, though it does not dictate clinical indications—only that it meets regulatory standards for diagnostic imaging devices.

Does the device’s AI integration affect how clinicians operate it, and what specific benefits does it provide during imaging?

Yes, the Kosmos incorporates artificial intelligence to assist with real-time image acquisition, probe guidance, and optimization of image clarity. This feature helps clinicians achieve better diagnostic confidence by reducing manual adjustments, improving first-pass success rates, and enhancing visualization of structures—particularly valuable in time-sensitive or complex cases where precision matters.

What safety considerations should be noted regarding the Kosmos’ use in MRI environments?

The Kosmos is explicitly designed for MRI-safe environments per manufacturer specifications, meaning it adheres to safety standards that prevent interference or hazards in magnetic resonance settings. However, facilities must verify compatibility with their specific MRI protocols and follow all manufacturer guidelines to ensure safe integration into interventional or diagnostic workflows.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Point of Care Ultrasound Technology (POCUS) With AI | EchoNous, Kosmos AI-driven POCUS device - EchoNous, EchoNous, Inc. Announces CE Mark Approval for Its Healthcare AI KOSMOS ..., KOSMOS - echonous.es

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
EchoNous, Inc.

Sources (2)

  • FDA 510(k) K193518 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026