MAGNETOM Cima.X Fit

K232765

Siemens Medical Solutions USA, Inc. · cleared 2024-02-29 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The subject device, MAGNETOM Cima.X Fit 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).”

AlgorithmAI network

source quote (p.9)

“The information below shows an executive summary of training and validation dataset of the AI features: Deep Resolve Boost: ... Deep Resolve Sharp: ... 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)No

source quote (p.10)

“The acquired datasets (as described above) represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

endpoints: equivalent safety and performance profile; perform as intended

standards: AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 14971, ANSI AAMI IEC 62366-1, IEC 62304, NEMA MS 6-2008, NEMA PS 3.1-3.20 (2022d), AAMI ANSI ISO 10993-1

Retrospective clinical

n=1,000,000 cases

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels

Retrospective clinical

n=10,000 images

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); perceptual loss; visual rating; evaluation of image sharpness by intensity profile comparisons of reconstructions with and without Deep Resolve Sharp

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

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).