# K250436: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Shenzhen Magnetic Resonance, Ltd.
- Decided: Jun 16, 2025 after 122 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: 21 generations back to K971684 (1997). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
8 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232535: MAGNETOM Sola; MAGNETOM Altea, Siemens Medical Solutions USA, Inc. (2023) Summary page 6.

## Most influential descendants
- 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, depending on optional local coils that have been configured with the system, 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/K250436
Methodology: https://510kreport.com/methodology