# K981358: Artoscan S

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Jul 13, 1998 after 90 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911667 (1991). 13 ancestors in all.
50 later devices descend from it; 1 cites 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)
- K963262: Artoscan M, Biosound, Inc. (1997) Summary page 1.
- K945155: AIRIS, Hitachi Medical Systems America, Inc. (1995) Summary page 1.
- K970990: Gyrex Prima 1TG 1.0T Mri System, Elscint Mr, Inc. (1997) Summary page 1.

## Most influential descendants
- K990968: E-SCAN (1999), 49 descendants of its own
- 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

## Indications for use
The Artoscan S 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.

Source page: https://510kreport.com/device/K981358
Methodology: https://510kreport.com/methodology