# K041145: Modification to E-Scan XQ Mri System

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: May 14, 2004 after 11 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: 6 generations back to K911667 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990968: E-SCAN, Biosound Esaote, Inc. (1999) Summary page 1.
- K001894: Modification to E-Scan, Biosound Esaote, Inc. (2000) Summary page 1.
- K012728: E-Scan Mri System, Biosound Esaote, Inc. (2001) Summary page 1.
- K020164: E-Scan XQ, Biosound Esaote, Inc. (2002) Summary page 1.
- K032121: Modification to E-Scan XQ, Esaote, S.p.A. (2003) Summary page 1.

## 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 upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, and imaging portions of the lower limb, 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/K041145
Methodology: https://510kreport.com/methodology