# K260595: Sonosite iLOOK Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: FUJIFILM Sonosite, Inc.
- Decided: Mar 10, 2026 after 15 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). 202 ancestors in all.
No later device cites it as a predicate yet.
6 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180704: SonoSite iViz Ultrasound System, FUJIFILM Sonosite, Inc. (2018) Summary page 6.

## Indications for use
The Sonosite LOOK Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: *Pediatric *Peripheral vessel *Needle Guidance Modes of operation include: B Mode (B), Color Power Doppler, Color Velocity Doppler, Multi-beam imaging, and combined modes, including duplex imaging: B+C. This device is indicated for Prescription Use Only. The Sonosite LOOK system is intended to be used in medical practices, clinical environments, including healthcare facilities, hospitals, clinics, and clinical point-of-care for diagnosis of patients. The system includes a transducer and a display connected together wirelessly. The transducer is powered by battery, while the display is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

Source page: https://510kreport.com/device/K260595
Methodology: https://510kreport.com/methodology