# K180737: Ultrasound Scanner System bk2300

- Pathway: 510(k) (Traditional)
- Applicant: Bk Medical Aps
- Decided: Aug 1, 2018 after 132 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: 15 generations back to K894632 (1989). 134 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161960: bk2300, Bk Medical Aps (2016) Summary page 4.

## Most influential descendants
- K222441: Ultrasound System 2300 (2022), 1 descendant of its own
- K223830: Ultrasound System 2300 (2023), 0 descendants of its own

## 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, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular). Contraindications: The 2300 Ultrasound System 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/K180737
Methodology: https://510kreport.com/methodology