# K220575: MAGNETOM Free.Max, MAGNETOM Free.Star

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 24, 2022 after 116 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K971684 (1997). 57 ancestors in all.
3 later devices descend from it; 1 cites it directly.
5 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210611: MAGNETOM Free.Max, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.

## Most influential descendants
- K231617: MAGNETOM Free.Max; MAGNETOM Free.Star (2023), 2 descendants of its own
- K251822: MAGNETOM Free.Max; MAGNETOM Free.Star (2025), 1 descendant of its own
- K260758: MAGNETOM Free.Max; MAGNETOM Free.Star (2026), 0 descendants of its own

## Recalls of this device
- Sep 1, 2023 · Class II · Z-2648-2023: In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. Thes

## Indications for use
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MIRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K220575
Methodology: https://510kreport.com/methodology