ECHELON Synergy MRI System

K241429

FUJIFILM Healthcare Corporation · cleared 2024-08-13 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware
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.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: Test data confirmed that new feature perform as intended for diagnostic use.

standards: ANSI / AAMI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and A2:2010/(R) 2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod)., IEC 60601-2-33 Edition 3.2 b:2015, medical electrical equipment - part 2-33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic., IEC 62304 Edition 1.1 2015-06, CONSOLIDATED VERSION medical device software - software life cycle processes., IEC 60601-1-2 Edition 4.1:2020-09, CONSOLIDATED VERSION medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests., NEMA MS 1-2008, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic Resonance Images, NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images, NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images, NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices, NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging, NEMA MS 8-2016, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems, NEMA Standards Publication MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems, IEC 60825-1 Edition 2.0 2007-03, Safety of laser products – Part 1: Equipment classification and requirements [including: Technical Corrigendum 1 (2008) interpretation Sheet 1 (2007) Interpretaion Sheet 2 (2007)]

Retrospective clinical

sample size not stated

endpoints: ensure that images from the new feature meet user needs; evaluate clinical usability; acceptable image quality for clinical use

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
2
drift signals on this device
  • 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/K241429