# K053154: MYLAB15/20 3D/4D Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Dec 16, 2005 after 32 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: 7 generations back to K924432 (1993). 43 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014168: AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication), Biosound Esaote, Inc. (2002) Summary page 1.
- K043588: Mylab 15 / Mylab 20, Model 2700, Pie Medical (2005) Summary page 1.
- K043455: SA8000 SE Diagnostic Ultrasound System, Medison Co., Ltd. (2004) Summary page 1.
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K061755: MYLAB15/20 New Indications Ultrasound System (2006), 28 descendants of its own
- K070903: MYLAB40 (2007), 27 descendants of its own
- K083882: Mylabfive (2009), 26 descendants of its own
- K101605: Mylabone Ultrasound System (2010), 25 descendants of its own
- K111302: Mylabseven, Mylabalpha (2011), 24 descendants of its own

## Indications for use
The following table provides the intended clinical use for the MyLab15/20:

Source page: https://510kreport.com/device/K053154
Methodology: https://510kreport.com/methodology