# K070903: MYLAB40

- Pathway: 510(k) (Traditional)
- Applicant: Esaote Europe B.V.
- Decided: Jul 2, 2007 after 91 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K924432 (1993). 61 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043588: Mylab 15 / Mylab 20, Model 2700, Pie Medical (2005) Summary page 2.
- K053154: MYLAB15/20 3D/4D Ultrasound Imaging System, Pie Medical (2005) Summary page 2.
- K061755: MYLAB15/20 New Indications Ultrasound System, Esaote Europe B.V. (2006) Summary page 2.
- K040596: Ultrasound Imaging System, Model 7300, Esaote, S.p.A. (2004) Summary page 2.
- K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150, Esaote, S.p.A. (2005) Summary page 2.
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100, Esaote, S.p.A. (2006) Summary page 2.

## Most influential descendants
- 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
- K132231: Mylabseven, Mylabalpha (2013), 22 descendants of its own

## Indications for use
Esaote's MyLab4O is a compact console ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal and Other: Urologic.

Source page: https://510kreport.com/device/K070903
Methodology: https://510kreport.com/methodology