# K222365: Leltek Ultrasound Imaging System (Model: LU700 Series)

- Pathway: 510(k) (Traditional)
- Applicant: Leltek, Inc.
- Decided: Oct 25, 2022 after 82 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: 22 generations back to K935595 (1995). 215 ancestors in all.
7 later devices descend from it; 3 cite 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)
- K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series), Leltek, Inc. (2021) Summary page 5.

## Most influential descendants
- 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
- K261132: Healium Intelliscan LX192LC (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 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: 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) LU710L 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) LU710LH 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) LU700C General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter) 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) LU710M 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 LU710E 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 clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Source page: https://510kreport.com/device/K222365
Methodology: https://510kreport.com/methodology