FDA.reportPublic FDA data

Uscan Mobile Stand

Primary DI
09353278000076
Brand
Uscan Mobile Stand
Company
ECHONOUS, INC.
Model
P005425
Device description
Radiological imaging system transport kit
Published
2019-11-11
Public version status
New
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
09353278000076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353278000076093532780000769353278000076

GMDN Terms#

Term, Definition table
TermDefinition
Radiological imaging system transport kitA collection of devices intended to support the transport and utilization of a portable or mobile radiological imaging system (e.g., a portable/mobile ultrasound system). It typically consists of portable or mobile containers, a stand, and sometimes items such as a kickstand, tripod, and holder for mounting/securing mobile system components (e.g. imaging display unit, probes).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080481089
Device count
1
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

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