MAGNETOM Sola; MAGNETOM Altea

K232535

Siemens Medical Solutions USA, Inc. · cleared 2023-12-22 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“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. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. AI Features/Applications training and validation: The information below shows an executive summary of training and validation dataset of the AI features:”
AlgorithmDeep Resolve Boost and Deep Resolve Sharp are AI features. 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).
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: ... 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.9)
“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 addressedYes
source quote (p.11)
“Risk Management is ensured via a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens Healthcare GmbH adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.”

Validation studies (2)

Bench

n=25,000 other

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

standards: ISO 14971 Third Edition 2019-12, 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, 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

Bench

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

standards: ISO 14971 Third Edition 2019-12, 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, 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

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
2
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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-10-01

    There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    recall event 97845 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-08-28

    There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    recall event 97530 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-08-28

    There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    recall event 97530 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-08-28

    There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    recall event 97530 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232535