ECHELON Synergy MRI system

K223426

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

Premarket evidence — what FDA accepted

Device typehardware
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.”
AlgorithmDeep Learning Reconstruction (DLR), AutoPose, AutoClip
source quote (p.8)
“Following functions are added as powered by Machine Learning - AutoPose (Knee, Shoulder, Spine) -AutoClip -Deep Learning Reconstruction (DLR)”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Reader study (MRMC)

n=110 cases · 2 site(s)

endpoints: image quality; signal to noise ratio; sharpness; lesion conspicuity; motion artifacts; acceptable for routine examinations

Standalone

n=40 cases · 1 site(s)

endpoints: performance substantially equivalent to manual clipping

Standalone

n=232 cases · 1 site(s)

endpoints: reduce the time and number of steps in the slice positioning; show the same time and number of steps as the manual 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
3
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223426