FDA.reportPublic FDA data

LELTEK

Primary DI
04719882150036
Brand
LELTEK
Company
LELTEK INC.
Model
LU710C
Catalog number
LU710C
Published
2025-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719882150036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719882150036047198821500364719882150036

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Regulatory Flags#

DUNS number
656116467
Device count
1
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719882150081LELTEKLU710PALU710PA2025-10-22
04719882150098LELTEKLU710ELU710E2025-10-22
04719882150104LELTEKLU710LHLU710LH2025-10-22
04719882150111LELTEKLK128CLK128C2025-10-22
04719882150128LELTEKLK128LLK128L2025-10-22
04719882150135LELTEKLK128MLK128M2025-10-22
04719882150142LELTEKLK128PALK128PA2025-10-22
04719882150159LELTEKLK128ELK128E2025-10-22
04719882150166LELTEKLK128LHLK128LH2025-10-22
04719882150173LELTEKLX192LCLX192LC2025-10-22
04719882150180LELTEKLX128LPLX128LP2025-10-22
04719882150197LELTEKLX128LCLX128LP2025-10-22
04719882150074LELTEKLU710M2022-10-26
04719882150067LeSonoLU700L2021-01-27
04719882150050LeSonoLU700C2021-01-18
04719882150043LeSonoLU700LU710L2021-01-18
04719882152054ASUSLU700C2021-08-11
04719882152061ASUSLU700L2021-08-11
04719882151019Norland at SwissrayLU700C2021-01-27
04719882151026Norland at SwissrayLU700L2021-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042849CA1-7SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
08800013544001X-CUBE 50Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013545008X-CUBE 60Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013511171C1-6CAlpinion Medical Systems Co., Ltd.IYN2022-07-15
08800013511164C1-7GTAlpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013542007X-CUBE i8Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013543004X-CUBE i9Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800076600119SC1FCUIYN2021-11-01
08800076600133Sono ChampionFCUIYN2021-11-01
08800076600140Sono ChangerFCUIYN2021-11-01
08800076600157Sono dot AIFCUIYN2021-11-01
08800076600010eZono1000FCUIYN2021-10-29
08800076600027Sonovation1LFCUIYN2021-10-29
08800076600034SOFRA1LFCUIYN2021-10-29
08800076600041SonoInfra1LFCUIYN2021-10-29
08800076600058Dr.SAFEFCUIYN2021-10-29
08800076600065ACUFRIENDFCUIYN2021-10-29
08800076600072ACUGUIDEFCUIYN2021-10-29
08800076600089ACUWAYFCUIYN2021-10-29
08800076600096AcuViz PocketFCUIYN2021-10-29