MAGNETOM Free.Max; MAGNETOM Free.Star

K251822

Siemens Shenzhen Magnetic Resonance , Ltd. · cleared 2025-11-20 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.10)

“Below Table 1 shows an executive summary of training and validation dataset of AI feature Deep Resolve Boost in subject devices:”

AlgorithmDeep Resolve Boost (AI feature)

source quote (p.10)

“Below Table 1 shows an executive summary of training and validation dataset of AI feature Deep Resolve Boost in subject devices:”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

sample size not stated

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); visual comparisons to evaluate for example, aliasing artifacts, image sharpness and denoising levels

standards: IEC 62304, ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS 4-2010, NEMA MS 9-2008, NEMA PS 3.1 - 3.20, ISO 10993-1

Prospective clinical

sample size not stated

endpoints: diagnostic image quality; safety

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

predicate_cohort_contagion
K251822 shares predicate K191040 with K253023 (BIOGRAPH One), whose product code OUO recorded 1 recall event(s) in the trailing 24 months.
first seen 2026-07-08 · predicate:K191040 sibling:K253023
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).