# K971684: Magnetom Project 047 System (Numaris 3.5 Software)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 5, 1997 after 90 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
442 later devices descend from it; 9 cite it directly.
22 of 443 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) SIEMENS MAGNETOM Vision: named in the summary without a submission number
- (no number) SIEMENS MAGNETOM Impact: named in the summary without a submission number

## Most influential descendants
- K032428: Magnetom Avanto MR System (2003), 431 descendants of its own
- K050200: Magnetom Trio a Tim System (2005), 428 descendants of its own
- K050199: Magnetom Symphony a Tim System (2005), 422 descendants of its own
- K041112: Magnetom Espree System (2004), 422 descendants of its own
- K052164: Magnetom Systems with Software Syngo MR 2006A (2005), 312 descendants of its own

## Recalls of this device
- Dec 1, 2007 · Not classified · Z-1046-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Dec 1, 2007 · Not classified · Z-1049-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Jul 28, 2004 · Not classified · Z-1399-04: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Jul 28, 2004 · Not classified · Z-1398-04: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

## Indications for use
The SIEMENS MAGNETOM Project 047 is a 1.5 Tesla whole body magnetic resonance imaging (MRI) system intended-for general diagrostic use: ‘This' MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging.

Source page: https://510kreport.com/device/K971684
Methodology: https://510kreport.com/methodology