MAGNETOM Sola; MAGNETOM Altea
K232535Siemens Medical Solutions USA, Inc. · cleared 2023-12-22 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The subject devices, MAGNETOM Sola and MAGNETOM Altea with software syngo MR XA61A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola with syngo MR XA51A (K221733). AI Features/Applications training and validation: The information below shows an executive summary of training and validation dataset of the AI features:”
source quote (p.9)
“AI Features/Applications training and validation: The information below shows an executive summary of training and validation dataset of the AI features: 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. 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). Most importantly, the performance was evaluated by visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels. The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and perceptual loss. In addition, the feature has been verified and validated by inhouse tests. These tests include visual rating and an evaluation of image sharpness by intensity profile comparisons of reconstructions with and without Deep Resolve Sharp.”
Validation studies (1)
Retrospective clinical
n=1,000,000 images
endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels; perceptual loss; visual rating; evaluation of image sharpness by intensity profile comparisons of reconstructions with and without Deep Resolve Sharp
standards: ISO 14971, IEC 60601-1, ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012, 60601-1-2 Edition 4.0:2014-02, 60601-2-33 Ed. 3.2 b:2015, 14971 Third Edition 2019-12, 62366-1:2015, 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, NEMA MS 6-2008 (R2014), PS 3.1 - 3.20 (2021e), 10993-1 Fifth edition 2018-08
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
- 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).