# K250791: ASUS Ultrasound Imaging System (LU800 series)

- Pathway: 510(k) (Traditional)
- Applicant: Asustek Computer, Inc.
- Decided: Dec 4, 2025 after 265 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.
No later device cites it as a predicate yet.
6 of 217 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 5.

## Indications for use
The ASUS Ultrasound Imaging System (Model: LU800 Series) is a software-based imaging system and accessories intended for use by qualified and trained 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: LU800L General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional), Musculoskeletal (superficial), Peripheral vessel , Other(Carotid), Pulmonary, interventional guidance(includes free hand needle/ catheter) LU800C Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac (adult), Cardiac(pediatric), Peripheral vessel, interventional guidance(includes free hand needle/ catheter) LU800M Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Urology, Musculoskeletal (conventional), OB/Gyn, Cardiac(adult), Cardiac (pediatric), Peripheral vessel LU800PA Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary LU800E Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Trans-rectal, Trans-vaginal, Urology, OB/Gyn, interventional guidance(includes 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/K250791
Methodology: https://510kreport.com/methodology