K242321
- 510(k) number
- K242321
- Device name
- Kosmos
- Applicant
- EchoNous, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-04-25
- Date received
- 2024-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242321
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.