Medical Device Manufacturer · US , Redmond , VA

EchoNous, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

Total

Cleared

Denied

EchoNous, Inc. has 5 FDA 510(k) cleared medical devices. Based in Redmond, US.

Latest FDA clearance: Apr 2025. Active since 2018. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by EchoNous, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - EchoNous, Inc.

5 devices

1-5 of 5

Cleared CT Aug 29, 2024

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Regulatory Technology Services, LLC

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 01, 2026

EchoNous, Inc. - FDA 510(k) Cleared Devices

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