# K132335: Ultrasound Scanner Flex Focus 1202

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Jan 10, 2014 after 168 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: 5 generations back to K000567 (2000). 8 ancestors in all.
66 later devices descend from it; 1 cites it directly.
0 of 75 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.
- K123254: Ultrasound Scanner Flex Focus, B-K Medical Aps (2013) Summary page 1.

## Most influential descendants
- 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
- K171034: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System (2017), 12 descendants of its own

## Recalls of this device
- Oct 9, 2025 · Class II · Z-0435-2026: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedure

## 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. An optional 3-Dl unit can reconstruct a series of 2-Dl images into a single 3-Dl 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. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose. Clinical applications: Abdominal, Cardiac, Fetal, lntraoperative, Neurosurgery, Obstetrics, Pediatrics,Transrectal, Small organs, Transvaginal, Musculoskeletal.

Source page: https://510kreport.com/device/K132335
Methodology: https://510kreport.com/methodology