# 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

- Pathway: 510(k) (Special)
- Applicant: Leltek, Inc.
- Decided: Sep 11, 2024 after 138 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: 23 generations back to K935595 (1995). 216 ancestors in all.
3 later devices descend from it; 2 cite it directly.
6 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222365: Leltek Ultrasound Imaging System (Model: LU700 Series), Leltek, Inc. (2022) Summary page 7.

## Most influential descendants
- K243226: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (2025), 1 descendant of its own
- K261288: Handheld Ultrasound Scanner (2026), 0 descendants of its own
- K261132: Healium Intelliscan LX192LC (2026), 0 descendants of its own

## Indications for use
The Ultrasound Imaging System (Model: 128 Series) and (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 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: LK128C Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/ EFAST,Nerve LK128L Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve LK128LH Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve LK128M Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LK128PA Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/ EFAST,Nerve LK128E Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans­rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter) LU700L General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve LU71OL Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve LU71OLH Ophthalmic,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter),Nerve LU700C General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel interventional guidance (free hand needle/ catheter),FAST/EFAST,Nerve LU710C Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Urology,Musculoskeletal (conventional),OB/Gyn, Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter),FAST/ EFAST,Nerve LU71OM Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic,Urology,Musculoskeletal (conventional),OB/Gyn,Cardiac (adult),Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter) LU710PA Fetal,General abdominal imaging,Pediatric,Cardiac (adult),Cardiac (pediatric),Pulmonary,FAST/ EFAST,Nerve LU71OE Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Trans-rectal,Trans-vaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter) 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/K241161
Methodology: https://510kreport.com/methodology