ECHELON Synergy V10.0
K233687Fujifilm Healthcare Americas Corporation · cleared 2024-05-03 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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 (TI), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. ... The validation results of the new features using machine learning (DLR Clear and AutoPose) were described below.”
source quote (p.12)
“The validation results of the new features using machine learning (DLR Clear and AutoPose) were described below. ... Function name of Deep Learning Reconstruction (DLR) added in ECHELON Synergy MRI System (K223426) is changed DLR Rise. DLR is an abbreviation for Deep Learning Reconstruction.”
Validation studies (6)
Bench
sample size not stated
endpoints: truncation artifact reduction; improvement of image sharpness; improvement of spatial resolution
Reader study (MRMC)
n=3 other
endpoints: image quality with DLR Clear in terms of the truncation artifact reduction; image sharpness; spatial resolution of image
Retrospective clinical
n=53 patients · 2 site(s)
endpoints: truncation artifact reduction; image sharpness; lesion conspicuity; overall image quality
Retrospective clinical
n=177 cases · 2 site(s)
endpoints: reduce time and number of steps in slice positioning
Retrospective clinical
n=66 cases · 2 site(s)
endpoints: reduce time and number of steps in slice positioning
Retrospective clinical
n=65 cases · 2 site(s)
endpoints: reduce 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
- 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).