# K260746: S-scan Open (100001800)

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Mar 27, 2026 after 21 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K911667 (1991). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161973: G-scan Brio, S-scan, Esaote, S.p.A. (2016) Summary page 5.

## Most influential descendants
- K261331: I-Genius (100019400) (2026), 0 descendants of its own

## Indications for use
The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. The indications for use are the following: imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh, hip, imaging the temporomandibular joint, imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, and imaging the head.

Source page: https://510kreport.com/device/K260746
Methodology: https://510kreport.com/methodology