# K063207: S-Scan Mri System

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Nov 9, 2006 after 17 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: 8 generations back to K911667 (1991). 34 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042236: G-SCAN, Esaote, S.p.A. (2004) Summary page 1.
- K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004, Esaote, S.p.A. (2006) Summary page 1.
- K043030: Magnetom C! MR System, Siemens Medical Solutions (2004) Summary page 1.
- K994345: Magna 5000 Phased Array CTL Spine Coil, Usa Instruments, Inc. (2000) Summary page 4.

## Most influential descendants
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera (2008), 24 descendants of its own
- K092469: O-Scan MR System (2009), 18 descendants of its own
- K110238: G-SCAN (2011), 15 descendants of its own
- K111803: G-SCAN (2011), 14 descendants of its own
- K122006: G-Scan Brio (2012), 11 descendants of its own

## 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/K063207
Methodology: https://510kreport.com/methodology