# K132466: Mylabseven 6400, Mylabalpha 7400

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Dec 4, 2013 after 119 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: 13 generations back to K935595 (1995). 145 ancestors in all.
22 later devices descend from it; 4 cite it directly.
1 of 168 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990360: AU6, Biosound Esaote, Inc. (1999) Summary page 1.
- K000681: AU5, AU6, Biosound Esaote, Inc. (2000) Summary page 1.
- K014168: AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication), Biosound Esaote, Inc. (2002) Summary page 1.
- K023255: Technos MP, Model AU6, Biosound Esaote, Inc. (2003) Summary page 1.
- K100931: Mylabtwice, Model 6200, Esaote, S.p.A. (2010) Summary page 1.
- K111302: Mylabseven, Mylabalpha, Esaote, S.p.A. (2011) Summary page 1.

## Most influential descendants
- 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
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own
- K141486: Mylabsix Ultrasound System (2014), 8 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, Intraoperative abdominal 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 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, Intraoperative abdominal 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/K132466
Methodology: https://510kreport.com/methodology