# K032121: Modification to E-Scan XQ

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Aug 13, 2003 after 35 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: 5 generations back to K911667 (1991). 18 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963262: Artoscan M, Biosound, Inc. (1997) Summary page 1.
- K990968: E-SCAN, Biosound Esaote, Inc. (1999) Summary page 1.
- K001894: Modification to E-Scan, Biosound Esaote, Inc. (2000)
- K012728: E-Scan Mri System, Biosound Esaote, Inc. (2001)
- K020164: E-Scan XQ, Biosound Esaote, Inc. (2002) Summary page 3.

## Most influential descendants
- K042236: G-SCAN (2004), 45 descendants of its own
- K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004 (2006), 43 descendants of its own
- 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

## Indications for use
E-scan XQ 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 XQ 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/K032121
Methodology: https://510kreport.com/methodology