# K083882: Mylabfive

- Pathway: 510(k) (Traditional)
- Applicant: Esaote Europe B.V.
- Decided: Jan 30, 2009 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: 10 generations back to K924432 (1993). 63 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070903: MYLAB40, Esaote Europe B.V. (2007) Summary page 2.
- K081794: Model 7340 Ultrasound System, Esaote, S.p.A. (2008) Summary page 2.

## Most influential descendants
- 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
- K142008: Mylabseven, Mylabalpha (2014), 19 descendants of its own

## Indications for use
Esaote's MyLabFive is a compact 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, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system provides imaging for guidance of biopsy and imaging to assist inthe placement of needles and catheters invascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Source page: https://510kreport.com/device/K083882
Methodology: https://510kreport.com/methodology