510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Echonous Inc

Redmond, WA, US

ECHONOUS, INC. appears in FDA device records in Redmond, WA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Echonous Inc between 2018 and 2025. The busiest year on record is 2018, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Echonous Inc, by decision year
YearClearances
20181
20201
20211
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242321KosmosIYNSubstantially Equivalent
K233826KosmosIYNSubstantially Equivalent
K212100KosmosIYNSubstantially Equivalent
K193518KOSMOSIYNSubstantially Equivalent
K181574UscanIYOSubstantially Equivalent

Registered establishments

FDA registered establishments for Echonous Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30137576963013757696ECHONOUS, INC.8310 154th Ave NE, Redmond, WA 98052 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2325-2024Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain