# K261288: Handheld Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Imgfax CO., LTD.
- Decided: Jul 30, 2026 after 101 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.
No later device cites it as a predicate yet.
6 of 218 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.

## Indications for use
The Imgfax Handheld Ultrasound Scanner 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: L12 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 LH20 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 C3 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 MC6 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) PA Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary, FAST/EFAST, Nerve EC6 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/K261288
Methodology: https://510kreport.com/methodology