# K043588: Mylab 15 / Mylab 20, Model 2700

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical
- Decided: Jan 25, 2005 after 28 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: 5 generations back to K924432 (1993). 16 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023512: Picus Ultrasound Imaging Systems, Pie Medical (2003) Summary page 1.
- K012887: SA6000II Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 1.

## Most influential descendants
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System (2005), 29 descendants of its own
- 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

## Indications for use
Esaote's MyLabI 5/MyLab2O is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).

Source page: https://510kreport.com/device/K043588
Methodology: https://510kreport.com/methodology