Elekta Solutions AB radiology AI products

FDA-cleared K252002

Monaco RTP System (6.3)

Elekta Solutions AB

Monaco RTP 6.3 creates external-beam radiation-treatment plans, calculates photon, electron, and proton dose distributions, and supports contouring, image fusion, optimization,...

Modality: Radiotherapy Planning Imaging
Anatomy: Patient anatomy represented in external-beam radiation-treatment plans
Decision: 2026-02-19

Radiotherapy planning

FDA-cleared K252188

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

Elekta Solutions AB

The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model:...

Modality: Radiotherapy Planning Imaging
Anatomy: Multi-region
Decision: 2026-01-15

Radiotherapy planning Oncology quantification

FDA-cleared K212218

Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB

Advanced Algorithms for Treatment Management Applications provides the cleared radiotherapy treatment-management functions described in K212218 for supported treatment-planning...

Modality: Radiotherapy Planning Imaging
Anatomy: Patient anatomy represented in external-beam radiation-treatment plans
Decision: 2021-10-25

Radiotherapy planning