MAGNETOM Cima.X

K231587

Siemens Medical Solutions USA, Inc. · cleared 2023-12-18 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The subject device, MAGNETOM Cima.X with software syngo MR XA61A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693).”

Algorithmdeep learning-based image reconstruction network

source quote (p.11)

“Clinical feasibility of accelerated diffusion weighted imaging of the abdomen with deep learning reconstruction: Comparison with conventional diffusion weighted imaging, Eur J Radiol., 154 (2022)”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=25,000 images

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); aliasing artifacts; image sharpness; denoising levels; perceptual loss; visual comparisons; visual rating

Bench

sample size not stated

endpoints: Software verification and validation; Performance bench test; Electrical, mechanical, structural, and related system safety test; Electrical safety and electromagnetic compatibility (EMC); SNR and image uniformity measurements for coils; Heating measurements for coils

standards: AAMI / ANSI ES60601-1, IEC 60601-2-33, IEC 60601-1-2, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

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) K232765 (decision 2024-02-29) from Siemens Medical Solutions USA, Inc. for a matching device line ("MAGNETOM Cima.X Fit") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232765
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).