# K143298: Ultrasound Scanner System bk2300

- Pathway: 510(k) (Abbreviated)
- Applicant: Bk Medical Aps
- Decided: Jan 16, 2015 after 60 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: 4 generations back to K000567 (2000). 9 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043524: Ultrasound Scanner Pro Focus, Model 2202, B-K Medical A/S (2005) Summary page 10.
- K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202, B-K Medical Aps (2011) Summary page 10.
- K140428: Ultrasound Scanner System BK2300, B-K Medical Aps (2014) Summary page 10.
- K130619: Acuson S1000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2013) Summary page 10.

## Most influential descendants
- K151910: Ultrasound Scanner System BK2300 (2015), 6 descendants of its own
- K161960: bk2300 (2016), 5 descendants of its own
- K180737: Ultrasound Scanner System bk2300 (2018), 2 descendants of its own
- K222441: Ultrasound System 2300 (2022), 1 descendant of its own
- K173569: Ultrasound System 1300 (2018), 1 descendant of its own

## 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
Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Source page: https://510kreport.com/device/K143298
Methodology: https://510kreport.com/methodology