# K142077: Mylabgamma

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Sep 12, 2014 after 43 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: 15 generations back to K935595 (1995). 159 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 165 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 21.
- K132231: Mylabseven, Mylabalpha, Esaote, S.p.A. (2013) Summary page 21.
- K132466: Mylabseven 6400, Mylabalpha 7400, Esaote, S.p.A. (2013) Summary page 21.
- K141486: Mylabsix Ultrasound System, Esaote Europe B.V. (2014) Summary page 5.

## Most influential descendants
- K161359: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System (2016), 4 descendants of its own
- K191072: 7410 Ultrasound System (MyLabSigma) (2019), 0 descendants of its own
- K190989: 6400 Ultrasound System (MyLabX6, MyLabX7) (2019), 0 descendants of its own
- K190447: 7400 Ultrasound Systems (2019), 0 descendants of its own
- K162290: MyLabSix CrystaLine (2016), 0 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 7410 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 and Other: Urologic. The 7410 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/K142077
Methodology: https://510kreport.com/methodology