# K121384: Mylabsogno

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: May 23, 2012 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K935595 (1995). 128 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 130 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 1.
- K110688: Mylabgold, Esaote (2011) Summary page 1.

## Most influential descendants
- K140677: Mylabssogno (2014), 0 descendants of its own

## Recalls of this device
- Mar 7, 2014 · Class II · Z-1331-2014: ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maxim

## Indications for use
Esaote's Model 7348 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac (adult and pediatric), Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Transvaginal, 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/K121384
Methodology: https://510kreport.com/methodology