# K132346: Ultrasound Scanner Pro Focus 2202

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Jan 10, 2014 after 165 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000567 (2000). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 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 1.
- K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202, B-K Medical Aps (2011) Summary page 1.

## Most influential descendants
- 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
- K231764: Ultrasound System 1300 (2023), 0 descendants of its own

## 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. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. An optionalt3-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 (VP!) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional liP wireless function with the ability to wireless transmit for printing and archive connectivity purpose. Clinical applications: Abdominal, Cardiac, Fetal, lntmaoperative, Neurosurgery, Obstetrics, PediatricsTransrectal, Small organs. Transvaginal. Musculoskeletal.

Source page: https://510kreport.com/device/K132346
Methodology: https://510kreport.com/methodology