# K990968: E-SCAN

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: May 27, 1999 after 65 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: 3 generations back to K911667 (1991). 14 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981358: Artoscan S, Biosound Esaote, Inc. (1998) Summary page 1.

## Most influential descendants
- K020164: E-Scan XQ (2002), 48 descendants of its own
- K032121: Modification to E-Scan XQ (2003), 47 descendants of its own
- 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

## Indications for use
The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information. The system preliminarily named “Artoscan S” is going to be commercialized under the trade name “E-Scan”. The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.

Source page: https://510kreport.com/device/K990968
Methodology: https://510kreport.com/methodology