MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

K250443

Siemens Healthcare GmbH · 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 the internal structure and/or function of the head, body, or extremities.”

AlgorithmDeep Resolve Boost and Deep Resolve Sharp, which are AI features for image reconstruction and enhancement, trained on various MRI data types (TSE, HASTE, EPI Diffusion, 2D images).

source quote (p.16)

“Deep Resolve Boost: TSE: more than 25,000 slices HASTE: pre-trained on the TSE dataset and refined with more than 10,000 HASTE slices EPI Diffusion: more than 1,000,000 slices The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. Deep Resolve Sharp: on more than 10,000 high resolution 2D images. The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength.”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (6)

Bench

sample size not stated

Retrospective clinical

sample size not stated

endpoints: image quality assessment

Bench

sample size not stated

Bench

sample size not stated

endpoints: SNR and image uniformity measurements for coils; Heating measurements for coils

Retrospective clinical

n=1,000,000 other

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

Retrospective clinical

n=10,000 images

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

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).