# K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Dec 16, 2011 after 623 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: 3 generations back to K000567 (2000). 5 ancestors in all.
82 later devices descend from it; 5 cite it directly.
0 of 88 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.

## Most influential descendants
- K123254: Ultrasound Scanner Flex Focus (2013), 68 descendants of its own
- K132335: Ultrasound Scanner Flex Focus 1202 (2014), 66 descendants of its own
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162267: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2016), 53 descendants of its own
- K171233: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2017), 21 descendants of its own

## Indications for use
Ultrasound Scanner and transducers for B, Tissue and Contrast H-armonic lImaging, M, PW DCWD. Color Doppler.. Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geomnetrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. An optional 3 -D unit can reconstruct a series of 2-D images into a single 3-D Volume and display this on the screen. Clinical applications: Abdominal, Cardiac, Fetal, lntraoperative, Neurosurgery, Obstetrics, Pediatric s,TFran srectalI, Small organs, Transvaginal, Musculoskeletal. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K100919
Methodology: https://510kreport.com/methodology