# K140677: Mylabssogno

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Apr 25, 2014 after 38 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: 14 generations back to K935595 (1995). 129 ancestors in all.
No later device cites it as a predicate yet.
1 of 130 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121384: Mylabsogno, Esaote, S.p.A. (2012) Summary page 1.
- K081794: Model 7340 Ultrasound System, Esaote, S.p.A. (2008) Summary page 1.
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150, Esaote, S.p.A. (2009) Summary page 2.
- K110688: Mylabgold, Esaote (2011) Summary page 1.

## Indications for use
Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdominal, Laparoscopic and Other: Urologic. The 7348 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/K140677
Methodology: https://510kreport.com/methodology