MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

K203443

Siemens Medical Solutions USA, Inc. · cleared 2021-03-31 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.7)

“Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks which increases the perceived sharpness of the interpolated images.”

Algorithminterpolation algorithm based on trained convolutional neuronal networks

source quote (p.7)

“Deep Resolve Sharp is an interpolation algorithm based on trained convolutional neuronal networks which increases the perceived sharpness of the interpolated images.”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: ISO 10993-1:2009/(R)2013, IEC 60601-1-2 Edition 4.0 2014-02, ISO 14971 Second edition 2007-03-01, IEC 60601-2-33 Ed. 3.2 b:2015, IEC 62366-1:2015, IEC 62304:2006/A1:2016, NEMA MS 4-2010, NEMA MS 9-2008 (R2014), NEMA PS 3.1-3.20 (2016), IEC 60601-1:2005/(R)2012 and A1:2012

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) K232535 (decision 2023-12-22) from Siemens Medical Solutions USA, Inc. for a matching device line ("MAGNETOM Sola; MAGNETOM Altea") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232535
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).