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

The EMLA is an external beam radiation therapy system that assists licensed practitioners in delivering ionizing radiation to defined tumor target volumes while sparing normal tissue. It is available in six models (Elekta Synergy, Harmony, Infinity, Harmony Pro, VersaHD, and Evo) with varying configurations for entry-, mid-, and high-level clinical applications, including standard fractionation, hypofractionation, and stereotactic delivery techniques.

Key differences include: Elekta Harmony Pro supports additional photon energies (4–15 MV) and electron energies compared to predicate Harmony; Elekta Evo supports same energies as predicate VersaHD; linac treatment control system has improved cybersecurity and supports integrated beam gating per IEC 60601-2-1 Ed. 4; kV imaging includes improved volume reconstruction (FDK algorithm) and new High Definition Reconstruction with machine-learning scatter correction for pelvic anatomies; beam gating uses new Integrated interface compliant with IEC 60601-2-1 and NEMA RT 1-2014.

IEC 60601-2-1 Ed. 4, IEC 60601-2-68, IEC 61217, IEC 60976, IEC 60601-1-2, ISO 14971, IEC 60601-1-6, IEC 62366-1, IEC 62304, ISO 20417, ISO 15223-1, CR 34971, ISO 10993-1, and ANSI AMI ES60601-1.

The subject devices have the same intended use and indications as the predicate (K210500). Non-clinical performance testing demonstrates that technological changes—primarily in cybersecurity, kV imaging reconstruction algorithms, and beam gating interface—do not raise different safety or effectiveness questions. Test results show the subject devices meet applicable consensus standards and perform as well as or better than the predicate, with improved image quality in uniformity and spatial resolution without adverse impact to registration accuracy.