MAGNETOM Free.Max, MAGNETOM Free.Star

K220575

Siemens Medical Solutions USA, Inc. · cleared 2022-06-24 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware

source quote (p.3)

“The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities.”

Algorithmauto registration with detection of patient height, weight and orientation; automatic real-time calculation of parameter maps

source quote (p.6)

“myExam 3D Camera: auto registration with detection of patient height, weight and orientation are supported in the subject device software version syngo MR XA50A. Inline Perfusion: Automatic real-time calculation of parameter maps with Inline technology based on image data acquired with the ep2d_fid pulse sequence type.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: SNR and image uniformity measurements for coils; Heating measurements for coils

standards: Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Standalone

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K231617 (decision 2023-11-09) from Siemens Medical Solutions USA, Inc. for a matching device line ("MAGNETOM Free.Max; MAGNETOM Free.Star") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231617
recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).