FDA.reportPublic FDA data

Hub - Refurbished

Primary DI
09353278000199
Brand
Hub - Refurbished
Company
ECHONOUS, INC.
Model
R005324
Device description
An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers.
Published
2019-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181574000UscanEchoNous, Inc.2018-07-10IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353278000199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353278000199093532780001999353278000199

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080481089
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353278000878Kosmos OTS iOS Software Package (5.0)v5.0P0087912026-03-25
09353278000830KosmosP0080422025-08-08
09353278000847KosmosP0080412025-08-08
09353278000823Kosmos OTS iOS iOS 4.X2025-02-21
09353278000854Kosmos LinkP0083922025-02-21
09353278000441Kosmos Torso - RefurbishedR0060252020-12-11
09353278000465Kosmos Accessories - US - RefurbishedR0062082020-12-11
09353278000489Binaural Headset - RefurbishedR0061152020-12-11
09353278000137Kosmos TorsoP0060252020-05-06
09353278000212Kosmos Binaural HeadsetP0061152020-05-06
09353278000250Kosmos Accessories - InternationalP0061052020-05-06
09353278000267Kosmos Accessories - USP0062082020-05-06
09353278000144Kosmos ECG Patient Cable - USP0057792020-05-06
09353278000243Kosmos ECG Patient Cable - InternationalP0061862020-05-06
09353278000762Kosmos OTS iOS P0079442024-05-06
09353278000656Kosmos UPP0065982022-02-08
09353278000632Kosmos Power PackP0076402023-03-10
09353278000724Kosmos Power Pack (Refurbished)R0076402023-03-10
09353278000663EchoNous Samsung S8 Tablet with SoftwareP0076352023-03-08
09353278000670EchoNous Samsung S8 Tablet with Software (Refurbished)R0076352023-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042542EV2-12SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042603CV1-8ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYO2025-10-13