# K110688: Mylabgold

- Pathway: 510(k) (Traditional)
- Applicant: Esaote
- Decided: Jun 2, 2011 after 83 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 12 generations back to K935595 (1995). 127 ancestors in all.
25 later devices descend from it; 5 cite it directly.
1 of 153 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.
- K032875: Aloka Model SSD-5500 V6.0 Ultrasound System, Aloka Co. Ltd USA (2003) Summary page 1.
- K033311: Aloka SSD-5000 V5.0 Ultrasound System, Aloka Co., Ltd. (2003) Summary page 1.
- K003739: Aloka SSD-4000, Aloka Co., Ltd. (2000) Summary page 1.
- K040719: Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory, Aloka Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K132231: Mylabseven, Mylabalpha (2013), 22 descendants of its own
- K142008: Mylabseven, Mylabalpha (2014), 19 descendants of its own
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 descendants of its own
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own

## Recalls of this device
- Jun 26, 2014 · Class II · Z-2167-2014: Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maxim

## 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, Musculo-Skeletal (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 Musculo-Skeletal applications. The 7340 system provides imaging for venous system flow profile.

Source page: https://510kreport.com/device/K110688
Methodology: https://510kreport.com/methodology