# K984221: Functional Mri Package for Magetetom Vision MR

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Corp.
- Decided: Feb 12, 1999 after 79 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.
20 later devices descend from it; 2 cite it directly.
0 of 21 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: named in the summary without a submission number
- (no number) Magnetom Symphony: named in the summary without a submission number

## Most influential descendants
- K031779: Cadstream (2003), 19 descendants of its own
- K041286: Dynacad V1.0 (2004), 17 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own

## Indications for use
The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems, provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K984221
Methodology: https://510kreport.com/methodology