MAGNETOM Amira; MAGNETOM Sempra

K223343

Siemens Medical Solutions USA Inc. · cleared 2023-03-28 · 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.”

AlgorithmAI features (Deep Resolve Boost and Deep Resolve Sharp)

source quote (p.7)

“Below Table 1 shows an executive summary of training and validation dataset of AI features (Deep Resolve Boost and Deep Resolve Sharp) in subject devices:”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=427 patients

endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); visual inspection for artefacts; perceptual loss; visual rating; image sharpness by intensity profile comparisons

standards: ES60601-1:2005/(R) 2012 and A1:2012, 60601-1-2 Edition 4.0:2014-02, 60601-2-33 Ed. 3.2:2015, 14971:2019, 62366 Edition 1.0 2015, 62304 Edition 1.1 2015-06, NEMA MS 6-2008 (R2014), PS 3.1 - 3.20 (2016), 10993-1:2018/(R) 2013

Bench

sample size not stated

endpoints: SNR and image uniformity measurements for coils; Heating measurements for coils; Software verification and validation; Sample clinical images

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

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).