# K251822: MAGNETOM Free.Max; MAGNETOM Free.Star

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Shenzhen Magnetic Resonance, Ltd.
- Decided: Nov 20, 2025 after 160 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: 18 generations back to K971684 (1997). 59 ancestors in all.
1 later device descends 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)
- K231617: MAGNETOM Free.Max; MAGNETOM Free.Star, Siemens Medical Solutions USA, Inc. (2023) Summary page 7.

## Most influential descendants
- K260758: MAGNETOM Free.Max; MAGNETOM Free.Star (2026), 0 descendants of its own

## Indications for use
MAGNETOM Free.Max: The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, 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 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 or dentist trained in MRI yield information that may assist in diagnosis. The MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. When operated by dentists and dental assistants trained in MRI, the MAGNETOM MR system must only be used for scanning the dentomaxillofacial region. MAGNETOM Free.Star: The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, 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 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/K251822
Methodology: https://510kreport.com/methodology