# K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Leltek, Inc.
- Decided: Nov 3, 2021 after 264 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: 21 generations back to K935595 (1995). 214 ancestors in all.
8 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)
- K191235: Leltek Ultrasound Imaging System, Leltek, Inc. (2020) Summary page 4.

## Most influential descendants
- 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
- K261288: Handheld Ultrasound Scanner (2026), 0 descendants of its own

## Indications for use
The Leltek Ultrasound Imaging System (Model: LU700 Series) 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 clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients 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). Specific clinical applications and exam types including: LU700C General abdominal imaging, musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and OB/Gyn. LU700L General abdominal imaging, small organ (breast, thyroid), musculoskeletal (conventional), musculoskeletal (superficial) and peripheral vessel. LU710C Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710M Fetal, abdominal, pediatric, small organ (thyroid, prostate, scrotum, breast), musculoskeletal (conventional), urology, gynecology, cardiac adult, cardiac pediatric and peripheral vessel. LU710PA Fetal, abdominal, pediatric, cardiac adult, cardiac pediatric. LU710E Fetal, abdominal, small organ (thyroid, prostate, scrotum, breast), trans-rectal, trans-vaginal, urology, gynecology.

Source page: https://510kreport.com/device/K210432
Methodology: https://510kreport.com/methodology