# K161359: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jul 19, 2016 after 64 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K935595 (1995). 167 ancestors in all.
4 later devices descend from it; 4 cite it directly.
1 of 172 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142008: Mylabseven, Mylabalpha, Esaote, S.p.A. (2014) Summary page 5.
- K142077: Mylabgamma, Esaote, S.p.A. (2014) Summary page 7.
- K110688: Mylabgold, Esaote (2011) Summary page 55.
- K061961: Art Lab Software, Pie Medical (2006) Summary page 55.
- K101605: Mylabone Ultrasound System, Esaote Europe B.V. (2010) Summary page 55.
- K113156: Sonosite Edge Ultrasound System, Sonosite,Inc. (2011) Summary page 55.

## Most influential descendants
- 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
- Sep 8, 2020 · Class II · Z-3052-2020: The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical s
- Sep 8, 2020 · Class II · Z-3053-2020: The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical s
- 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 (Abdominal), Laparoscopic and Other: Urologic. Model 6400 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), Laparoscopic and Other: Urologic. Model 7400 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 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, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. Model 7410 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/K161359
Methodology: https://510kreport.com/methodology