FDA.reportPublic FDA data

LELTEK

Primary DI
04719882150135
Brand
LELTEK
Company
LELTEK INC.
Model
LK128M
Catalog number
LK128M
Device description
The Ultrasound Imaging System is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD).
Published
2025-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719882150135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719882150135047198821501354719882150135

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

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
04719882150036LELTEKLU710CLU710C2025-10-22
04719882150081LELTEKLU710PALU710PA2025-10-22
04719882150098LELTEKLU710ELU710E2025-10-22
04719882150104LELTEKLU710LHLU710LH2025-10-22
04719882150111LELTEKLK128CLK128C2025-10-22
04719882150128LELTEKLK128LLK128L2025-10-22
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
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-08-18