# K092469: O-Scan MR System

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Dec 23, 2009 after 134 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: 10 generations back to K911667 (1991). 44 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040877: Artoscan C, Esaote, S.p.A. (2004) Summary page 1.
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera, Esaote, S.p.A. (2008) Summary page 1.
- K001334: Hitachi Airis II, Hitachi Medical Systems America, Inc. (2000) Summary page 1.

## Most influential descendants
- K110238: G-SCAN (2011), 15 descendants of its own
- K111803: G-SCAN (2011), 14 descendants of its own
- K122006: G-Scan Brio (2012), 11 descendants of its own
- K133490: G-Scan Brio (2013), 10 descendants of its own
- K142421: G-scan Brio (2015), 9 descendants of its own

## Indications for use
0-scan is a Magnetic Resonance (MIR) 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 and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, calf and knee, but excluding the thigh. 0-scan 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 (TI), 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 informnation.

Source page: https://510kreport.com/device/K092469
Methodology: https://510kreport.com/methodology