BIOGRAPH One

K253023

Siemens Healthineers AG · cleared 2026-01-15 · product code OUO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.12)

“Below table shows an executive summary of training and validation dataset of new AI features in the subject devices.”

AlgorithmDeep Resolve Boost and Deep Resolve Sharp deep learning networks

source quote (p.12)

“Below table shows an executive summary of training and validation dataset of new AI features in the 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 (4)

Standalone

n=1,265 other

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

standards: IEC 62304, ISO 14971

Standalone

n=500 other

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); perceptual loss; image sharpness by intensity profile comparisons

standards: IEC 62304, ISO 14971

Standalone

sample size not stated

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); learned perceptual image patch similarity metrics (LPIPS); banding artifact reduction capabilities; radiologist evaluation of suitability for clinical diagnostics

standards: IEC 62304, ISO 14971

Bench

sample size not stated

standards: ISO 10993-1, ANSI AAMI ES60601-1, IEC 60601-2-33, IEC 60601-1-2, NEMA NU 2-2024

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

predicate_cohort_contagion
K253023 shares predicate K191040 with K251822 (MAGNETOM Free.Max; MAGNETOM Free.Star), whose product code LNH recorded 100 recall event(s) in the trailing 24 months.
first seen 2026-07-08 · predicate:K191040 sibling:K251822
predicate_cohort_contagion
K253023 shares predicate K191040 with K252838 (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), whose product code LNH recorded 100 recall event(s) in the trailing 24 months.
first seen 2026-07-08 · predicate:K191040 sibling:K252838
predicate_cohort_contagion
K253023 shares predicate K250436 with K260265 (MAGNETOM Flow.Ace; MAGNETOM Flow.Plus), whose product code LNH recorded 100 recall event(s) in the trailing 24 months.
first seen 2026-07-08 · predicate:K250436 sibling:K260265

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).