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.10)
“The Elekta Medical Linear Accelerator (EMLA) is an external beam, image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. ... 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.”
Algorithmmachine learning method where a neural network is trained to estimate scatter in the projection domain.
source quote (p.12)
“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)No
source quote (p.12)
“Simulated Monte Carlo data is used to train the network.”
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 (7)

Bench

sample size not stated

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

standards: IEC 60601-2-68

Bench

sample size not stated

endpoints: image registration accuracy

Bench

sample size not stated

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

standards: IEC 60601-2-68

Retrospective clinical

n=124 cases

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

Bench

sample size not stated

endpoints: image registration accuracy

Retrospective clinical

n=13 cases

endpoints: image registration accuracy

Retrospective clinical

sample size not stated

endpoints: qualitative image quality preference

Reported performance (2 observations)

accuracyas written: “accuracy of registration”stated without value
source quote (p.15)
“The conclusion from performance tests carried out to demonstrate the ability of the improved FDK based reconstruction function to reconstruct a CBCT volume image which is suitable for visualizing anatomies to enable certain clinical judgment, and which is suitable for automatic registration with a specified precision is that the subject device has improved image quality in uniformity, volume outline and spatial resolution, with no adverse impact to the accuracy of registration.”
accuracyas written: “HU accuracy”stated without value
source quote (p.15)
“Elekta Harmony Pro, Versa HD and the Elekta Evo: the conclusion from performance tests carried out to demonstrate the ability of the HD reconstruction function to reconstruct a CBCT volume image which is suitable for visualizing the pelvic anatomies to enable certain clinical judgment, and which is suitable for automatic registration with a specified precision is that image quality has improved in terms of a better uniformity and HU accuracy.”

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

13
recalls in product code, 24mo
48
MAUDE reports in code, 12mo
-54%
vs code's own 3-yr baseline
9
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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (ELEKTA SOLUTIONS AB) — same firm and product code, not necessarily this device · 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.

    recall event 97562 (openFDA)

  • Recalling firm matches this device's applicant (ELEKTA SOLUTIONS AB) — same firm and product code, not necessarily this device · initiated 2021-09-28

    There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

    recall event 88771 (openFDA)

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/K252188