# K060827: MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: May 19, 2006 after 53 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: 7 generations back to K924432 (1993). 46 ancestors in all.
62 later devices descend from it; 9 cite it directly.
0 of 109 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.
- K050326: 7350 Ultrasound Imaging System, Model 7350, Esaote, S.p.A. (2005) Summary page 1.
- K051308: Mylab 70 Ultrasound Imaging System, Esaote, S.p.A. (2005) Summary page 1.
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100, Esaote, S.p.A. (2005) Summary page 1.
- K043455: SA8000 SE Diagnostic Ultrasound System, Medison Co., Ltd. (2004) Summary page 1.
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 1.

## Most influential descendants
- K081794: Model 7340 Ultrasound System (2008), 57 descendants of its own
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90) (2008), 53 descendants of its own
- K091009: MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60, Model 6150 (2009), 51 descendants of its own
- K100931: Mylabtwice, Model 6200 (2010), 46 descendants of its own
- K103152: 6250 Ultrasound Sytems (2011), 35 descendants of its own

## Indications for use
Esaote's Model 7300 (MyLab3O) 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, and Other: Urologic. Esaote's Model 7350 (MyLab5O) 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, and Other: Urologic. Esaote's Model 6150 (MyLab7O) 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, and Other: Urologic. Esaote's Model 6100 (MyLab9O) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Adult Cephalic, Laparoscopic, Intraoperative: Abdominal, and Other Urologic.

Source page: https://510kreport.com/device/K060827
Methodology: https://510kreport.com/methodology