# K253310: 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Nov 25, 2025 after 57 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: 23 generations back to K935595 (1995). 339 ancestors in all.
No later device cites it as a predicate yet.
7 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243253: 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70), Esaote, S.p.A. (2025) Summary page 5.
- K241671: 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85), Esaote, S.p.A. (2025) Summary page 6.

## Indications for use
The multifunctional ultrasound scanner is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main applications - Cardiac Districts: Cardiac Adult, Cardiac Pediatric (including newborns) Invasive access: Transesophageal - Vascular Districts: Neonatal, Adult Cephalic, Vascular Invasive access: Not applicable - General Imaging Districts: Abdominal, Musculo-skeletal, Neonatal, Pediatric, Small Organ (Testicles, Breast, Thyroid), Urologic Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal - Women Health Districts: OB/Fetal, Gynecology Invasive access: Transrectal, Transvaginal The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI. The ultrasound scanner is suitable for use in health institutions and is designed for ultrasound practitioners.

Source page: https://510kreport.com/device/K253310
Methodology: https://510kreport.com/methodology