FDA.reportPublic FDA data

ArtUs

Primary DI
04772057000277
Brand
ArtUs
Company
TELEMED UAB
Model
C5-2H60-A5
Device description
Ultrasound transducer convex array
Published
2023-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211248000ArtUsTelemed2022-02-11IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04772057000277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04772057000277047720570002774772057000277

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+37052106272support@pcultrasound.com

Regulatory Flags#

DUNS number
366590052
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04772057000635ArtUsC15-7N30-A42024-08-09
04772057000253ArtUsEXT-1H2023-01-20
04772057000260ArtUsC6-1H50-A52023-01-20
04772057000284ArtUs L15-7H40-A52023-01-20
04772057000291ArtUsL18-7H30-A52023-01-20
04772057000307ArtUsP5-1S15-A62023-01-20
04772057000420MicrUs MC4-2R20S-32023-01-20
04772057000437MicrUs MC10-5R10S-32023-01-20
04772057000550ArtUsL12-5N40-A42023-01-20
04772057000567ArtUsLF9-5N60-A32023-01-20
04772057000574ArtUsLF11-5H60-A32023-01-20
04772057000581MicrUs EXT-1H Rev.E2023-01-20
04772057000598ArtUsEXT-2H2023-01-20
04772057000338MicrUs ProL40S2021-04-22
04772057000345MicrUs ProL40N2021-04-22
04772057000352MicrUs ProC60S2021-04-22
04772057000109MicrUsEXT-1H2017-04-30
04772057000116MicrUsL15-6L25S-32017-05-02
04772057000123MicrUsL12-5L40S-32017-06-28
04772057000130MicrUsC5-2R60S-32017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029512LA3-16ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029604L3-22SAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029611LA3-22AISAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029741EA2-11AVESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029789EA2-11ARESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07