# K081154: Ultrasound Scanner Flex Focus, Model 1202

- Pathway: 510(k) (Special)
- Applicant: B-K Medical Aps
- Decided: May 23, 2008 after 30 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: 3 generations back to K000567 (2000). 5 ancestors in all.
76 later devices descend from it; 4 cite it directly.
0 of 82 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
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K081154
Methodology: https://510kreport.com/methodology