MAGNETOM Vida with syngo MR XA50A

K213693

Siemens Medical Solutions USA, Inc. · cleared 2022-02-25 · 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.”

Algorithmdeep learning-based image reconstruction algorithm

source quote (p.5)

“Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction. - Deep Resolve Boost is a novel deep learning-based image reconstruction algorithm for 2D TSE data, which reconstructs images from k-space raw-data.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Image quality assessments; Software verification and validation

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) K220939 (decision 2022-04-29) from Siemens Medical Solutions USA Inc. for a matching device line ("MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220939
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).