# K142421: G-scan Brio

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Apr 9, 2015 after 224 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911667 (1991). 49 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133490: G-Scan Brio, Esaote, S.p.A. (2013) Summary page 4.
- K111803: G-SCAN, Esaote, S.p.A. (2011) Summary page 4.

## Most influential descendants
- K151668: S-scan (2015), 8 descendants of its own
- K153039: MRI Dynamic Analysis Plus (2016), 7 descendants of its own
- K161238: S-scan (2016), 6 descendants of its own
- K161973: G-scan Brio, S-scan (2016), 5 descendants of its own
- K212419: Magnifico Open, Magnifico MSK (2022), 2 descendants of its own

## Recalls of this device
- Jun 6, 2016 · Class II · Z-2124-2016: The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for 

## Indications for use
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column. G-scan Brio 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 use of MR equipment, the images can provide diagnostically useful information.

Source page: https://510kreport.com/device/K142421
Methodology: https://510kreport.com/methodology