ECHONOUS, INC.

FDA Device Registration & Listing · Redmond, WA, US · Registration 3013757696

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013757696
FEI Number
3013757696
Entity Name
ECHONOUS, INC.
City/State/Country
Redmond, WA, US
Establishment Address
8310 154th Ave NE, Building B, Suite 200, Redmond, WA 98052, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ECHONOUS, INC. (Owner Number: 10055454)
Owner / Operator Contact Address
8310 154th Ave NE, Building B, Suite 200, Redmond, WA 98052, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233826
PMA Number
N/A

All Registered Proprietary Names

Kosmos Signos AI Station 2 Kosmos Kosmos ECG Connector Kosmos Bridge Kosmos Platform Kosmos OTS Application Kosmos Binaural Headset Kosmos Torso-One Kosmos Torso-One – USB Kosmos Lexsa Kosmos Hub Kosmos Torso KOSMOS Kosmos Power Pack Uscan

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-08
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-09-08
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-05-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2018-05-15
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-08-06
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2021-08-06
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2021-08-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-08-06
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-08-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-07-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2017-07-26
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2022-01-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-11-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-11-01
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2024-11-01
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-01
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-11-01
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-11-01

Official Correspondent

Joshua Kim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ECHONOUS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013757696. Last updated year: 2026. Please use registration number 3013757696 when referencing this establishment in official correspondence.
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