# K231617: MAGNETOM Free.Max; MAGNETOM Free.Star

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 9, 2023 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: 17 generations back to K971684 (1997). 58 ancestors in all.
2 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)
- K220575: MAGNETOM Free.Max, MAGNETOM Free.Star, Siemens Medical Solutions USA, Inc. (2022) Summary page 5.

## Most influential descendants
- 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

## Indications for use
MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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. MAGNETOM Free.Max may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. MAGNETOM Free.Star system is indicated for use as a magnetic resonance diagnostic device (MRDD) that 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/K231617
Methodology: https://510kreport.com/methodology