# K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jul 25, 2006 after 63 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: 8 generations back to K911667 (1991). 36 ancestors in all.
32 later devices descend from it; 3 cite it directly.
0 of 69 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.
- K032121: Modification to E-Scan XQ, Esaote, S.p.A. (2003) Summary page 1.
- K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004, Esaote, S.p.A. (2006) Summary page 1.
- K984224: Perfusion Package for Magnetom Vision and Symphony Systems, Siemens Corp. (1999) Summary page 1.
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K080968: S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera (2008), 24 descendants of its own
- K092469: O-Scan MR System (2009), 18 descendants of its own
- 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

## Indications for use
The Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera MRI Systems allows the acquisition of MR dynamic image datasets and the post processing display of temporal variations in the acquired datasets, showing changes in contrast over time. Its purpose is to provide time intensity curves that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K061429
Methodology: https://510kreport.com/methodology