MAGNETOM Avanto Fit

K220151

Siemens Medical Solutions USA, Inc. · cleared 2022-04-01 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware

source quote (p.3)

“Your 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.”

AlgorithmTSE MoCo (image-based motion correction), Automatic fiducial detection (for MR Breast Biopsy), AbsoluteShim (shimming procedure based on a 3-echo gradient echo protocol), Fast GRE RefScan (speed-optimized reference scan for GRAPPA and SMS kernel calibration).

source quote (p.6)

“TSE MoCo: TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type. Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection. AbsoluteShim: The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol. Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.7)

“The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards. 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.”

Validation studies (4)

Retrospective clinical

sample size not stated

endpoints: Image quality assessments; comparison of the image quality / quantitative data

Bench

sample size not stated

Bench

sample size not stated

Bench

sample size not stated

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

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) K232494 (decision 2023-11-14) from Siemens Medical Solutions USA, Inc. for a matching device line ("MAGNETOM Avanto fit; MAGNETOM Skyra fit") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232494
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).