# K203443: MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 31, 2021 after 128 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K971684 (1997). 39 ancestors in all.
20 later devices descend from it; 7 cite it directly.
14 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192924: MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K213693: MAGNETOM Vida with syngo MR XA50A (2022), 13 descendants of its own
- K221733: MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit (2022), 9 descendants of its own
- K232535: MAGNETOM Sola; MAGNETOM Altea (2023), 4 descendants of its own
- K232482: MAGNETOM Viato.Mobile (2023), 4 descendants of its own
- K240608: MAGNETOM Viato.Mobile (2024), 3 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2658-2025: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, l
- Aug 16, 2021 · Class II · Z-2447-2021: Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the trea

## Indications for use
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Source page: https://510kreport.com/device/K203443
Methodology: https://510kreport.com/methodology