# K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: May 4, 2006 after 27 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: 7 generations back to K911667 (1991). 29 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032121: Modification to E-Scan XQ, Esaote, S.p.A. (2003) Summary page 1.
- K945517: Magnetom Vision (Project 016), Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K042236: G-SCAN, Esaote, S.p.A. (2004) Summary page 1.

## Most influential descendants
- K063207: S-Scan Mri System (2006), 34 descendants of its own
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera (2006), 32 descendants of its own
- 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

## Indications for use
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip. E-scan Opera MR 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 (T1), 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/K060956
Methodology: https://510kreport.com/methodology