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 (Tl), 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 ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The validation results of the new features using machine learning (DLR Symmetry and AutoPose) were described below.”

Algorithmmachine learning (DLR Symmetry and AutoPose)

source quote (p.13)

“The validation results of the new features using machine learning (DLR Symmetry and AutoPose) were described below.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.13)

“IEC 62304 Edition 1.1 2015-06, CONSOLIDATED VERSION medical device software - software life cycle processes.”

Validation studies (3)

Bench

sample size not stated

endpoints: artifact reduction; SNR; image sharpness; image contrast; Normalized Root Mean Square Error (NRMSE); Relative Edge Sharpness; Contrast Change Rate

standards: ANSI / AAMI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and A2:2010/(R) 2012, IEC 60601-2-33 Edition 3.2 b:2015, IEC 62304 Edition 1.1 2015-06, IEC 60601-1-2 Edition 4.1:2020-09, NEMA MS 1-2008, NEMA MS 2-2008, NEMA MS 3-2008, NEMA MS 4-2010, NEMA MS 5-2018, NEMA MS 8-2016, NEMA Standards Publication MS 14-2019, IEC 60825-1:2014

Reader study (MRMC)

n=89 patients

endpoints: artifact reduction; SNR; image sharpness; lesion conspicuity; overall image quality

standards: ANSI / AAMI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and A2:2010/(R) 2012, IEC 60601-2-33 Edition 3.2 b:2015, IEC 62304 Edition 1.1 2015-06, IEC 60601-1-2 Edition 4.1:2020-09, NEMA MS 1-2008, NEMA MS 2-2008, NEMA MS 3-2008, NEMA MS 4-2010, NEMA MS 5-2018, NEMA MS 8-2016, NEMA Standards Publication MS 14-2019, IEC 60825-1:2014

Retrospective clinical

n=554 cases

endpoints: ability to set the slice positions for a scan without manual adjustment

standards: ANSI / AAMI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and A2:2010/(R) 2012, IEC 60601-2-33 Edition 3.2 b:2015, IEC 62304 Edition 1.1 2015-06, IEC 60601-1-2 Edition 4.1:2020-09, NEMA MS 1-2008, NEMA MS 2-2008, NEMA MS 3-2008, NEMA MS 4-2010, NEMA MS 5-2018, NEMA MS 8-2016, NEMA Standards Publication MS 14-2019, IEC 60825-1:2014

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). 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).