# K123254: Ultrasound Scanner Flex Focus

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Feb 13, 2013 after 118 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: 4 generations back to K000567 (2000). 7 ancestors in all.
68 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081154: Ultrasound Scanner Flex Focus, Model 1202, B-K Medical Aps (2008) 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
- 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
- K170277: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System (2017), 20 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 optional 3-D unit can reconstruct a series of 2-0 images into a single 3-0 volume and display this on the screen. An optional Vector Flow Imaging (WFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Clinical applications: Abdominal, Cardiac, Fetal, lntraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Source page: https://510kreport.com/device/K123254
Methodology: https://510kreport.com/methodology