EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)

K252188

Elekta Solutions AB · cleared 2026-01-15 · product code IYE · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.11)

“It includes an AI-ML based component to estimate the scatter to enable its automatic removal from the projection images acquired by the imager ahead of the volume reconstruction.”

Algorithmiterative reconstruction method (Polyquant) with a machine learning neural network for scatter correction

source quote (p.12)

“The defining characteristic of the Elekta Harmony Pro, VersaHD and Elekta Evo is the introduction of an additional reconstruction pipeline, called High Definition Reconstruction which implements an iterative reconstruction method (Polyquant) which uses ordered subset and steepest descent with total variation regularization to reconstruct the 3D image and takes the spectral properties of the x-ray beam into account. The High Definition Reconstruction implements a scatter correction method using a machine learning method where a neural network is trained to estimate scatter in the projection domain.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“The control system of the subject device has improvements to cybersecurity.”

Validation studies (4)

Bench

sample size not stated

endpoints: uniformity; spatial resolution; low contrast visibility; geometric accuracy; image registration accuracy

standards: ANSI AMI ES60601-1:2005/(R)2012, IEC 60601-2-1 Edition 4.0 2020-10, IEC 60601-2-68 Edition 1.0 2014-09, IEC 60601-1-3, IEC 61217:2011-12 Edition 2.0, IEC 60976:2007-10 Edition 2.0, IEC 60601-1-2:2014, ISO 14971:2019-12, IEC 60601-1-6 Edition 3.1 2013-10, IEC 62366-1 Edition 1.0 2015-02, IEC 62304:2006 / A1:2016, ISO 20417:2021-04 1.0 Edition, ISO 15223-1:2021-07 4.0 Edition, CR 34971:2022, ISO 10993-1:2018-08 5th Edition

Retrospective clinical

n=124 other

endpoints: uniformity; Hounsfield Unit consistency; signal-to-noise ratio; contrast-to-noise ratio; contrast consistency

Retrospective clinical

n=13 other

endpoints: Image registration accuracy

Reader study (MRMC)

sample size not stated

endpoints: clinical image quality evaluation; user preference

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-54%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code IYE (ELEKTA SOLUTIONS AB, initiated 2025-09-17): "When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule." Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97562
recall_reason_pattern
Software/algorithm-related recall in product code IYE (Accuray Incorporated, initiated 2026-06-16): "In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99075
recall_reason_pattern
Software/algorithm-related recall in product code IYE (Accuray Incorporated, initiated 2026-06-16): "In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and i" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99083
recall_reason_pattern
Software/algorithm-related recall in product code IYE (Elekta, Inc., initiated 2026-05-21): "Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98980
recall_reason_pattern
Software/algorithm-related recall in product code IYE (Elekta, Inc., initiated 2025-12-10): "Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or l" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98116
recall_reason_pattern
Software/algorithm-related recall in product code IYE (Zap Surgical Systems, initiated 2025-07-25): "If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automat" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97413
…and 3 more.

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).