FDA.reportPublic FDA data

MicrUs Pro

Primary DI
04772057000352
Brand
MicrUs Pro
Company
TELEMED UAB
Model
C60S
Device description
Ultrasound system, imaging, general purpose, portable.
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161968000MicrUsTelemed2016-11-03IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04772057000352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04772057000352047720570003524772057000352

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

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
04772057000277ArtUsC5-2H60-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
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
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455017MyLabA50ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAIYO2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAIYO2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAIYO2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAIYO2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAIYO2025-07-07
08056304455628MyLabE80ESAOTE SPAIYO2024-03-29
08056304455628MyLabE80ESAOTE SPAITX2024-03-29
08056304454980MyLabX90ESAOTE SPAITX2023-12-14
08056304454980MyLabX90ESAOTE SPAIYO2023-12-14
08056304455031MyLabOmega eXPESAOTE SPAIYO2023-12-14
08056304454676MyLabX9ESAOTE SPAITX2023-06-13
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONIYO2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONITX2021-11-29
08056304454386MyLabX75ESAOTE SPAIYO2021-09-24
08033737713037THD Procto Software SystemTHD SPAITX2021-07-19