# K100670: S-Scan, Model 9800020010

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Apr 5, 2010 after 27 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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: 10 generations back to K911667 (1991). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera, Esaote, S.p.A. (2008) Summary page 2.

## Indications for use
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for 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 and hip and imaging portions of the spinal column, including the cervical and lumbo-sacral sections. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K100670
Methodology: https://510kreport.com/methodology