# K133905: 6200 / 6250 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Apr 15, 2014 after 113 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: 16 generations back to K935595 (1995). 172 ancestors in all.
34 later devices descend from it; 2 cite it directly.
1 of 207 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100931: Mylabtwice, Model 6200, Esaote, S.p.A. (2010) Summary page 2.
- K103152: 6250 Ultrasound Sytems, Esaote, S.p.A. (2011) Summary page 2.
- K081386: Model 6150 (MYLAB70) and Model 6100 (MYLAB90), Esaote, S.p.A. (2008) Summary page 2.
- K123564: Logiq E9 Diagnostic Ultrasound System, GE Healthcare (2012) Summary page 4.

## Most influential descendants
- 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
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own

## Indications for use
Esaote's Model 6200 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 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. Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, 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 software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image. Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological examinations only. 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/K133905
Methodology: https://510kreport.com/methodology