# K103152: 6250 Ultrasound Sytems

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jan 7, 2011 after 73 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: 12 generations back to K935595 (1995). 117 ancestors in all.
35 later devices descend from it; 1 cites 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)
- K051308: Mylab 70 Ultrasound Imaging System, Esaote, S.p.A. (2005) 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.
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90), 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.

## Most influential descendants
- K133905: 6200 / 6250 Ultrasound System (2014), 34 descendants of its own
- K161999: Aixplorer (2016), 20 descendants of its own
- K171105: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (2017), 19 descendants of its own
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), 18 descendants of its own
- K180572: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (2018), 16 descendants of its own

## Indications for use
Esaote's Model 6250 isa 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), Laparoscopic and Other: Urologic. The 6250 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. The Virtual Navigator is a Mytab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular. The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information. The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Source page: https://510kreport.com/device/K103152
Methodology: https://510kreport.com/methodology