# K984224: Perfusion Package for Magnetom Vision and Symphony Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Corp.
- Decided: Feb 2, 1999 after 69 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
No predicates in its family tree.
33 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MAGNETOM Vision MR system: named in the summary without a submission number
- (no number) SYMPHONY MR system: named in the summary without a submission number

## Most influential descendants
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera (2006), 32 descendants of its own
- 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

## Indications for use
The Perfusion Package for MAGNETOM Vision and Symphony MR Systems is a software package which allows the display of temporal variations in dynamic MR Datasets, showing changes in contrast over time. Its purpose is to provide either time intensity curves or the creation of parametric images for parameters like time to peak that support the diagnostic process. These images when interpreted by a trained physician, yield information that may assist in diagnosis. One clinical application where this could be useful is the diagnosis of lesions by temporal analysis of tumor enhancement.

Source page: https://510kreport.com/device/K984224
Methodology: https://510kreport.com/methodology