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Ultrasound Imaging System (LK128L) +13 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241161

by Leltek Inc.

Identifiers

510(k) Number
K241161 FDA 510(k)
FDA Product Code
IYN FDA 510(k)
Models / Variants
Ultrasound Imaging System (LK128L) FDA 510(k)
Ultrasound Imaging System (LK128LH) FDA 510(k)
Ultrasound Imaging System (LK128C) FDA 510(k)
Ultrasound Imaging System (LK128M) FDA 510(k)
Ultrasound Imaging System (LK128PA) FDA 510(k)
Ultrasound Imaging System (LK128E) FDA 510(k)
Ultrasound Imaging System (LU700C) FDA 510(k)
Ultrasound Imaging System (LU700L) FDA 510(k)
Ultrasound Imaging System (LU710L) FDA 510(k)
Ultrasound Imaging System (LU710LH) FDA 510(k)
Ultrasound Imaging System (LU710C) FDA 510(k)
Ultrasound Imaging System (LU710M) FDA 510(k)
Ultrasound Imaging System (LU710PA) FDA 510(k)
Ultrasound Imaging FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ultrasound Imaging System is a diagnostic medical device designed to produce images of internal body structures. It utilizes ultrasound technology to assist in clinical visualization for various radiological applications.

This device has received FDA 510(k) clearance. It is supplied as a system for professional use in clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Leltek Inc.
FDA Applicant
Leltek, Inc.

Sources (1)

  • FDA 510(k) K241161 24 fields · synced Oct 6, 2026