# K061755: MYLAB15/20 New Indications Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote Europe B.V.
- Decided: Aug 7, 2006 after 47 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: 8 generations back to K924432 (1993). 44 ancestors in all.
28 later devices descend from it; 1 cites 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 3.
- K043588: Mylab 15 / Mylab 20, Model 2700, Pie Medical (2005) Summary page 1.
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System, Pie Medical (2005) Summary page 1.

## Most influential descendants
- 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
- K132466: Mylabseven 6400, Mylabalpha 7400 (2013), 22 descendants of its own

## Indications for use
Esaote’s MyLab15/MyLab20 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), Intraoperative: Abdominal, and Other: Urological.

Source page: https://510kreport.com/device/K061755
Methodology: https://510kreport.com/methodology