MAGNETOM Free.Max

K210611

Siemens Medical Solutions USA, Inc. · cleared 2021-07-01 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The subject device, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet.”

AlgorithmThe device includes software features named Deep Resolve Gain and Deep Resolve Sharp, which are associated with image denoising and image super-resolution using techniques like Residual Dense Networks and Perceptual Losses, as indicated by cited clinical publications.

source quote (p.6)

“Deep Resolve Gain Deep Resolve Sharp”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (3)

Standalone

sample size not stated

Bench

sample size not stated

Prospective clinical

n=12 patients

endpoints: Peripheral Nerve Stimulation (PNS) effects

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220575 (decision 2022-06-24) 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:K220575
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).