# K163082: 6200 Ultrasound System and 6250 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Mar 16, 2017 after 133 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 333 ancestors in all.
9 later devices descend from it; 1 cites it directly.
7 of 343 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153277: 6200 Ultrasound System and 6250 Ultrasound System, Esaote, S.p.A. (2016) Summary page 4.
- K130881: Acuson S2000 and S3000, Siemens Medical Solutions USA, Inc. (2013) Summary page 45.
- K150239: FibroScan, Echosens (2015) Summary page 45.
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0, Toshibamedical Systems Corporation (2015) Summary page 45.
- K134016: Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound Scanner, Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (2014) Summary page 45.

## Most influential descendants
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own
- K230179: 6440 MyLabX90 (2023), 4 descendants of its own
- K192157: 6450 Ultrasound system (2019), 4 descendants of its own
- K243253: 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (2025), 2 descendants of its own
- K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (2025), 2 descendants of its own

## Recalls of this device
- Jan 3, 2018 · Class II · Z-1138-2018: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
- Jan 3, 2018 · Class II · Z-1137-2018: The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

## 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), Intraoperative (Neurological), 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), Intraoperative (Neurological), 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, PET and others). 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, Musculoskeletal, Obstetrics, Pediatric, Urologic, Small Organs, Intraoperative (Abdominal), Intraoperative (Neurological), 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 is contraindicated for patients, operators, personnel and other people who use an electronic life support device (such as a cardiac pacemaker or defibrillator).

Source page: https://510kreport.com/device/K163082
Methodology: https://510kreport.com/methodology