# K970852: Magnetom Project 024 System (Numaris 3.5 Software)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 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: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
247 later devices descend from it; 5 cite it directly.
1 of 248 devices in its family (counting itself) has 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 Impact: named in the summary without a submission number

## Most influential descendants
- K052423: Magnetom Systems with Syngo Expert - I Option (2006), 199 descendants of its own
- K061964: Syngo Multimodality Workplace (2006), 180 descendants of its own
- K072728: Syngo Multimodality Workplace (2008), 178 descendants of its own
- K081734: Syngo Imaging (Version V31) (2008), 177 descendants of its own
- K092519: Syngo.X (2009), 176 descendants of its own

## Recalls of this device
- Dec 1, 2007 · Not classified · Z-1045-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Dec 1, 2007 · Not classified · Z-1042-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Dec 1, 2007 · Not classified · Z-1043-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Dec 1, 2007 · Not classified · Z-1047-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Dec 1, 2007 · Not classified · Z-1048-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Dec 1, 2007 · Not classified · Z-1044-2008: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Jul 28, 2004 · Not classified · Z-1396-04: 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-1397-04: 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 STEMENS MAGNETOM Project 024 is a 1Tesla whole body magnetic resonance imaging (MRI) system intended for general diagnostic 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 exhlbxtmg 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/K970852
Methodology: https://510kreport.com/methodology