# K081794: Model 7340 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jul 10, 2008 after 15 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: 8 generations back to K944485 (1995). 48 ancestors in all.
57 later devices descend from it; 9 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040596: Ultrasound Imaging System, Model 7300, Esaote, S.p.A. (2004) Summary page 1.
- 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.
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100, Esaote, S.p.A. (2005) Summary page 1.

## Most influential descendants
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own
- K083882: Mylabfive (2009), 26 descendants of its own
- K110688: Mylabgold (2011), 25 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, Laparoscopic, Intraoperative Abdominal, and Other Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Source page: https://510kreport.com/device/K081794
Methodology: https://510kreport.com/methodology