# K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: May 18, 2009 after 39 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: 11 generations back to K935595 (1995). 116 ancestors in all.
51 later devices descend from it; 7 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)
- K051308: Mylab 70 Ultrasound Imaging System, Esaote, S.p.A. (2005) Summary page 2.
- 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.
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90), Esaote, S.p.A. (2008) Summary page 1.
- K081794: Model 7340 Ultrasound System, Esaote, S.p.A. (2008) Summary page 1.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K061682: GE Voluson E8 Ultrasound System, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own
- K110688: Mylabgold (2011), 25 descendants of its own
- K111302: Mylabseven, Mylabalpha (2011), 24 descendants of its own
- K132466: Mylabseven 6400, Mylabalpha 7400 (2013), 22 descendants of its own

## Indications for use
Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 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 6150 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6150 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/K091009
Methodology: https://510kreport.com/methodology