MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

K252838

Siemens Healthcare GmbH · cleared 2025-12-19 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD)”
AlgorithmNetworks and AI features characterized by image quality metrics such as PSNR, SSIM, NMSE, MSE, and LPIPS.
source quote (p.21)
“The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR), structural similarity index (SSIM) and normalized mean squared error (NMSE). Quantitative evaluations of structural similarity index (SSIM), peak signal-to-noise ratio (PSNR) and mean squared error (MSE) metrics showed a convergence of the training and improvements compared to conventional parallel imaging. The impact of the Deep Resolve Sharp network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and perceptual loss. The evaluation on the test dataset confirmed very similar metrics in terms of peak signal-to-noise ratio (PSNR), structural similarity index (SSIM) and learned perceptual image patch similarity metrics (LPIPS) for the predicate and the modified network with both outperforming conventional GRAPPA as the reference.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (4)

Retrospective clinical

n=29,740 other

endpoints: PSNR; SSIM; NMSE; visual inspection

Retrospective clinical

n=27,679 other

endpoints: SSIM; PSNR; MSE; visual inspection

Retrospective clinical

n=13,000 other

endpoints: PSNR; SSIM; perceptual loss; image sharpness by intensity profile comparisons; reduction of Gibb's artifacts

Retrospective clinical

n=23,250 other

endpoints: PSNR; SSIM; LPIPS; banding artifacts reduction; sharpness; detail visibility; radiologist evaluation

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
3
drift signals on this device
  • predicate_cohort_contagion

    K252838 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252838