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
K252838Siemens Healthcare GmbH · cleared 2025-12-19 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.10)
“The subject device, MAGNETOM Vida with software Syngo MR XB10, 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 XA60A (K231560).”
source quote (p.20)
“Below table shows an executive summary of training and validation dataset of new AI features in the subject devices.”
Validation studies (5)
Standalone
n=29,740 other
endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); normalized mean squared error (NMSE); visual inspection
Standalone
n=1,265 other
endpoints: structural similarity index (SSIM); peak signal-to-noise ratio (PSNR); mean squared error (MSE); inspection of test images
Standalone
n=500 other
endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); perceptual loss; rating and an evaluation of image sharpness by intensity profile comparisons
Standalone
n=25,000 other
endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); learned perceptual image patch similarity metrics (LPIPS); visual evaluations of banding artifacts; radiologist evaluation
Bench
sample size not stated
endpoints: Software verification and validation; Image quality assessment by sample clinical images; Performance bench test; Biocompatibility; Electrical safety and electromagnetic compatibility (EMC)
standards: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-2-33 Edition 4.0 2022-08, ISO 14971 Third edition 2019-12, IEC 62366-1: 2015 + AMD1:2020, IEC 62304:2006 + AMD1:2015, NEMA MS 4-2010, NEMA MS 9-2008, NEMA PS 3.1 - 3.20 (2023e), ANSI AAMI ISO 10993-1: 2018
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
- predicate_cohort_contagion
K252838 shares predicate K191040 with K253023 (BIOGRAPH One), whose product code OUO recorded 1 recall event(s) in the trailing 24 months.
first seen 2026-07-08 · predicate:K191040 sibling:K253023
- 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).