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Kosmos

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K212100

by EchoNous, Inc.

Identifiers

510(k) Number
K212100 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 diagnostic ultrasound imaging system, designed for real-time visualization of internal body structures using high-frequency sound waves. It is classified under the product code IYN (Ultrasound Imaging Systems) and is intended for radiologic examination and diagnostic purposes in clinical settings.

This device is supplied as a reusable medical instrument, requiring appropriate sterilization and maintenance protocols to ensure safety and functionality. It is authorized under FDA 510K clearance (K212100) and meets MDR compliance standards. The system is intended for use in radiology departments and clinical environments where ultrasound imaging is performed, adhering to standard operating procedures for medical imaging equipment.

Frequently asked questions

Is the Kosmos ultrasound system designed for single-use or can it be reused after proper sterilization?

The Kosmos is a reusable medical device, meaning it is intended to be used multiple times in clinical settings after undergoing appropriate sterilization and maintenance procedures to ensure safety and functionality. Since it is classified as a reusable instrument, healthcare facilities must follow established protocols for cleaning, disinfection, and sterilization to maintain its performance and prevent cross-contamination.

What types of clinical environments is the Kosmos ultrasound system intended for, and how is it typically deployed?

The Kosmos is designed for radiology departments and clinical environments where ultrasound imaging is performed. It is intended for real-time diagnostic visualization of internal body structures and adheres to standard operating procedures for medical imaging equipment in these settings. Its deployment aligns with typical ultrasound systems used in hospitals, outpatient clinics, and diagnostic centers.

How do I determine the correct model or size of the Kosmos system for my facility’s needs?

The provided specifications do not list specific model numbers or sizes, as the Kosmos is described as a diagnostic ultrasound imaging system without additional variants in the data. However, since it is classified under product code IYN (Ultrasound Imaging Systems), you should consult EchoNous, Inc. directly for detailed specifications, including available configurations, probe types, or software features, to ensure compatibility with your facility’s workflow and patient needs.

What regulatory pathways does the Kosmos follow, and how does this affect its use in the U.S.?

The Kosmos is authorized under FDA 510K clearance (K212100) with a Traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance allows it to be legally marketed and used in the U.S. for its intended purpose—radiologic examination and diagnostic ultrasound imaging—while adhering to FDA compliance standards. Additionally, it meets MDR (Medical Device Regulation) compliance, ensuring alignment with European regulatory requirements if applicable.

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.

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) K212100 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026