# K232535: MAGNETOM Sola; MAGNETOM Altea

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 22, 2023 after 123 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
Longest line of descent: 20 generations back to K971684 (1997). 42 ancestors in all.
4 later devices descend from it; 2 cite it directly.
8 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221733: MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit, Siemens Medical Solutions USA, Inc. (2022) Summary page 5.

## Most influential descendants
- K252838: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise (2025), 1 descendant of its own
- K250436: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (2025), 1 descendant of its own
- K260852: MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure (2026), 0 descendants of its own
- K260265: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (2026), 0 descendants of its own

## Indications for use
The 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. The 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/K232535
Methodology: https://510kreport.com/methodology