Leltek Ultrasound Imaging System LU700 Series
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Leltek Inc.
Identifiers
- 510(k) Number
- K222365 FDA 510(k)
- FDA Product Code
- IYN 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 Leltek Ultrasound Imaging System LU700 Series is a diagnostic ultrasound device designed for real-time imaging of internal body structures. It employs high-frequency sound waves to generate visual representations of tissues and organs, aiding in the evaluation of anatomical and pathological conditions across various medical specialties.
This system is intended for use in clinical settings such as hospitals, diagnostic imaging centers, and outpatient facilities. Supplied as a reusable medical device, it requires proper maintenance and sterilization protocols as specified by the manufacturer. The LU700 Series complies with FDA 510K clearance under the Radiology advisory committee, adhering to regulatory standards including the Medical Device Directive (MDD) and Medical Device Regulation (MDR).
Frequently asked questions
Is the Leltek Ultrasound Imaging System LU700 Series designed for single-use or can it be reused in a clinical setting?
The LU700 Series is supplied as a reusable medical device, meaning it is intended for repeated use in clinical settings like hospitals and diagnostic centers. Since it is reusable, it must undergo proper maintenance and sterilization as outlined by the manufacturer to ensure safety and functionality between uses.
What types of medical facilities is the Leltek Ultrasound Imaging System LU700 Series intended for?
The LU700 Series is specifically designed for use in clinical settings, including hospitals, diagnostic imaging centers, and outpatient facilities. Its real-time imaging capabilities support evaluations across various medical specialties, making it versatile for environments where internal body structure assessment is required.
How is the regulatory approval status of the Leltek Ultrasound Imaging System LU700 Series determined?
The LU700 Series holds FDA 510K clearance under the Radiology advisory committee, with a decision classification of *Substantially Equivalent* (SESE). It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), ensuring it meets regulatory standards for diagnostic ultrasound devices in both the U.S. and EU markets.
What kind of imaging does the Leltek Ultrasound Imaging System LU700 Series provide, and how is it used?
The LU700 Series generates real-time imaging of internal body structures using high-frequency sound waves, producing visual representations of tissues and organs. This aids clinicians in evaluating anatomical and pathological conditions, making it useful for diagnostic purposes in specialties like obstetrics, cardiology, and general surgery.
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 (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222365 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leltek Inc.
- FDA Applicant
- Leltek, Inc.
Sources (2)
- FDA 510(k) K222365 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026