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.8)
“BIOGRAPH One with software Syngo MR XB10 includes new and modified hardware and software compared to the predicate device, Biograph mMR with software syngo MR E11P-AP01. A high level summary of the new and modified hardware and software is provided below: Hardware New Hardware Gantry offset phantom SDB (Smart Distribution Box) New Coils BM Contour XL Coil BM Head/Neck Pro PET-MR Coil BM Spine Pro PET-MR Coil Transfer of up-to-date RF coils from the reference device MAGNETOM Vida. Modified Hardware Software New Features and Applications Fast Whole-Body workflows Fast Head workflow myExam PET-MR Assist CS-Vibe myExam Implant Suite DANTE blood suppression SMS Averaging for TSE SMS Averaging for TSE_DIXON SMS without diffusion function BioMatrix Motion Sensor RF pulse optimization with VERSE Deep Resolve Boost for FL3D_VIBE and SPACE Deep Resolve Sharp for FL3D_VIBE and SPACE Preview functionality for Deep Resolve Boost EP2D FID PHS EP_SEG_FID_PHS ASNR recommended protocols for imaging of ARIA Open Workflow Ultra HD-PET "MTC Mode" OpenRecon 2.0 Deep Resolve Boost for TSE GRE PC The following functions have been migrated for the subject device without modifications from MAGNETOM Skyra Fit and MAGNETOM Sola Fit: 3D Whole Heart”
AlgorithmDeep Resolve Boost network, Deep Resolve Sharp network
source quote (p.12)
“Below table shows an executive summary of training and validation dataset of new Al features in the subject devices. Deep Resolve Boost for FL3D_VIBE and Deep Resolve Boost for SPACE: Test result summary 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”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Standalone

n=1,265 images

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

Standalone

sample size not stated

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

Standalone

n=500 images

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); learned perceptual image patch similarity metrics (LPIPS)

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

1
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
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); 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/K253023