# K192157: 6450 Ultrasound system

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Nov 22, 2019 after 105 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: 21 generations back to K935595 (1995). 335 ancestors in all.
4 later devices descend from it; 2 cite it directly.
7 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173291: 6440 Ultrasound System, Esaote, S.p.A. (2018) Summary page 5.

## Most influential descendants
- K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (2025), 2 descendants of its own
- K253288: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (2026), 0 descendants of its own
- K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) (2025), 0 descendants of its own
- K212021: 6430 MyLabX75, 6430 MyLab XPro75 (2021), 0 descendants of its own

## Indications for use
Esaote's Model 6450, commercial names MyLabX8 and MyLabX8 eXP, is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, lntraoperative (Abdominal), Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes. The Virtual Navigator software option for Esaote 6450 system 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, Musculoskeletal, 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 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/K192157
Methodology: https://510kreport.com/methodology