ECHELON Synergy MRI system

K223426

FUJIFILM Healthcare Corporation · cleared 2023-07-13 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.”

AlgorithmDeep Learning Reconstruction (DLR), AutoClip, AutoPose Spine, AutoPose Shoulder, and AutoPose Knee are functions powered by Machine Learning.

source quote (p.10)

“The validation results of the new features using machine learning (DLR, AutoClip, AutoPose Spine, AutoPose Shoulder, and AutoPose Knee) were described below.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (4)

Reader study (MRMC)

n=81 cases

endpoints: signal to noise ratio; sharpness; lesion conspicuity; overall image quality

Retrospective clinical

n=110 cases

endpoints: clinical usability; image quality

Retrospective clinical

n=40 cases

endpoints: performance of AutoClip

Retrospective clinical

n=146 cases

endpoints: time and number of steps in slice positioning

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) K241429 (decision 2024-08-13) from FUJIFILM Healthcare Corporation for a matching device line ("ECHELON Synergy MRI System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241429
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).