MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit

K221733

Siemens Medical Solutions USA, Inc. · cleared 2022-09-13 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware

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.”

AlgorithmThe device includes software features such as myExam_Autopilot for simplified scan workflow, Open Recon Framework for container-based reconstruction algorithms, myExam Angio Advanced Assist for planning and execution of angiography examinations, and Beat Sensor Cardiac triggering for physiological triggering.

source quote (p.5)

“myExam_Autopilot is a simplified scan workflow designed for enabling less-MRI experience users to complete MRI routine Brain and Knee examinations successfully. Open Recon Framework interface allows to apply container-based reconstruction algorithms on the reconstruction systems. The Open Recon Framework only allows FDA cleared 3rd party algorithms to be imported for clinical use. myExam Angio Advanced Assist for Test Bolus examinations supports the clinical user in planning and execution of peripheral angiography examinations. Beat Sensor Cardiac triggering is a physiological triggering technique based on the pilot tone technology that has been adapted in the subject devices to allow for cardiac triggering with a wide range of sequences typically used in MRI examinations of the heart and great vessels”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

standards: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Bench

sample size not stated

standards: AAMI/ANSI ES60601-1, IEC 60601-2-33

Bench

sample size not stated

standards: IEC 60601-1-2

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).