# K243226: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)

- Pathway: 510(k) (Special)
- Applicant: Leltek, Inc.
- Decided: May 8, 2025 after 212 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: 24 generations back to K935595 (1995). 217 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Leltek, Inc. (2024) Summary page 5.

## Most influential descendants
- K261132: Healium Intelliscan LX192LC (2026), 0 descendants of its own

## Indications for use
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).Specific clinical applications and exam types including: LX Series: Ophthalmic,Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic, Trans-rectal, Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,Nerve 128 Series: Ophthalmic,Fetal, General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic, Trans-rectal, Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve LU700 Series: Ophthalmic,Fetal, General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic, Trans-rectal, Trans-vaginal,Urology,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve 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.

Source page: https://510kreport.com/device/K243226
Methodology: https://510kreport.com/methodology