# K152052: Ultrasound Scanner System bk2300

- Pathway: 510(k) (Special)
- Applicant: Bk Medical Aps
- Decided: Sep 16, 2015 after 55 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2325-2016: In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that 

## Indications for use
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Clinical Applications: • Fetal (Sometimes called Obstetrics) • Abdominal • Intra-operative • Intra-operative (Neuro) (sometimes called Neuro Surgical) • Pediatrics • Small Organ (Sometimes called Small Parts) • Neonatal Cephalic (Cephalic is sometimes called trans-cranial) • Adult Cephalic (Cephalic is sometimes called trans-cranial) • Trans-rectal • Trans-vaginal • Trans-urethral • Musculo-skeletal (Conventional) • Musculo-skeletal (Superficial) • Cardiac Adult • Peripheral Vessel (Sometimes called Peripheral Vascular) Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K152052
Methodology: https://510kreport.com/methodology