MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

K250436

Siemens Shenzhen Magnetic Resonance , Ltd. · cleared 2025-06-16 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body, or extremities.”
AlgorithmThe AI features Deep Resolve Boost, Deep Resolve Sharp, and Deep Resolve Swift Brain utilize a network, characterized by quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM).
source quote (p.10)
“The information below shows an executive summary of training and validation dataset of the AI features: Deep Resolve Boost: Deep Resolve Sharp: Deep Resolve Swift Brain: ... The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM).”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (4)

Standalone

n=1,000,000 images

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM)

Standalone

n=10,000 images

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); perceptual loss

Standalone

n=29,740 images

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); normalized mean squared error (NMSE)

Prospective clinical

n=12 patients

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
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K260265 (decision 2026-02-23) from Siemens Shenzhen Magnetic Resonance , Ltd. for a matching device line ("MAGNETOM Flow.Ace; MAGNETOM Flow.Plus") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K260265

  • 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/K250436