# K191235: Leltek Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Leltek, Inc.
- Decided: Feb 12, 2020 after 280 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 213 ancestors in all.
9 later devices descend from it; 1 cites it directly.
6 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172385: Clarius Ultrasound System, Clarius Mobile Health Corp. (2017) Summary page 5.

## Most influential descendants
- K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series) (2021), 8 descendants of its own
- K222365: Leltek Ultrasound Imaging System (Model: LU700 Series) (2022), 7 descendants of its own
- K241161: Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging (2024), 3 descendants of its own
- K243226: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (2025), 1 descendant of its own
- K242681: NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) (2025), 1 descendant of its own

## Indications for use
The Leltek Ultrasound Imaging System (Model: LU700) 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 device is intended for use in environments where healthcare is provided by trained healthcare professionals, but not intended for use in emergency medical service, ambulance, or aircraft. Specific clinical applications and exam types including: For LU700C: General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. 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). For LU700L: General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. The modes of operation includes B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode(B+M, B+CD, B+PWD).

Source page: https://510kreport.com/device/K191235
Methodology: https://510kreport.com/methodology