# K111302: Mylabseven, Mylabalpha

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jul 22, 2011 after 74 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: 12 generations back to K935595 (1995). 142 ancestors in all.
24 later devices descend from it; 6 cite it directly.
1 of 167 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050326: 7350 Ultrasound Imaging System, Model 7350, Esaote, S.p.A. (2005) Summary page 1.
- K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150, Esaote, S.p.A. (2005) Summary page 1.
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100, Esaote, S.p.A. (2006) Summary page 1.
- K081794: Model 7340 Ultrasound System, Esaote, S.p.A. (2008) Summary page 1.
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150, Esaote, S.p.A. (2009) Summary page 1.
- K101605: Mylabone Ultrasound System, Esaote Europe B.V. (2010) Summary page 1.

## Most influential descendants
- 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
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 descendants of its own

## Indications for use
Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. Esaote's Model 7400 is a compact ultrasound system ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Source page: https://510kreport.com/device/K111302
Methodology: https://510kreport.com/methodology