# K231764: Ultrasound System 1300

- Pathway: 510(k) (Traditional)
- Applicant: Bk Medical Aps
- Decided: Oct 23, 2023 after 129 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K894632 (1989). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173569: Ultrasound System 1300, Bk Medical Aps (2018) Summary page 5.

## Recalls of this device
- Oct 9, 2025 · Class II · Z-0436-2026: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedure

## Indications for use
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular). Modes of Operation: * 2D (B-Mode) (including Tissue Harmonic imaging) » M-Mode * Vector Flow Imaging (VFI) » Strain Elastography » CW Doppler * Contrast Imaging * PWD Mode * CFM Mode (Includes Color Doppler and Amplitude (Power) Doppler) Environment: The Ultrasound System 1300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices) Contraindications: The Ultrasound System 1300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.

Source page: https://510kreport.com/device/K231764
Methodology: https://510kreport.com/methodology