# K142008: Mylabseven, Mylabalpha

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Sep 12, 2014 after 51 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K935595 (1995). 158 ancestors in all.
19 later devices descend from it; 3 cite it directly.
1 of 178 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111302: Mylabseven, Mylabalpha, Esaote, S.p.A. (2011) Summary page 5.
- K132231: Mylabseven, Mylabalpha, Esaote, S.p.A. (2013) Summary page 5.
- K132466: Mylabseven 6400, Mylabalpha 7400, Esaote, S.p.A. (2013) Summary page 5.
- K081794: Model 7340 Ultrasound System, Esaote, S.p.A. (2008) Summary page 36.
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150, Esaote, S.p.A. (2009) Summary page 36.
- K110688: Mylabgold, Esaote (2011) Summary page 36.
- K051308: Mylab 70 Ultrasound Imaging System, Esaote, S.p.A. (2005) Summary page 37.
- K052805: MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150, Esaote, S.p.A. (2005) Summary page 37.
- K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100, Esaote, S.p.A. (2006) Summary page 37.
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90), Esaote, S.p.A. (2008) Summary page 37.

## Most influential descendants
- 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
- K230179: 6440 MyLabX90 (2023), 4 descendants of its own
- K192157: 6450 Ultrasound system (2019), 4 descendants of its own

## Recalls of this device
- Jun 11, 2018 · Class II · Z-0204-2019: The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the pr
- Jun 11, 2018 · Class II · Z-0205-2019: The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the pr
- Jun 11, 2018 · Class II · Z-0206-2019: The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the pr

## 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 abdomninal, Laparoscopic 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 abdomninal 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/K142008
Methodology: https://510kreport.com/methodology