Turn this list into an evaluation

Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Prepare with a buyer guide:

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

FDA-cleared K252002

Monaco RTP System (6.3)

Elekta Solutions AB

Authorized purpose: Monaco RTP 6.3 creates external-beam radiation-treatment plans, calculates photon, electron, and proton dose distributions, and supports contouring, image fusion, optimization, quality assurance, review, and export.

Modality
Radiotherapy Planning Imaging
Anatomy
Patient anatomy represented in external-beam radiation-treatment plans
Decision
2026-02-19
FDA-cleared K252188

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

Elekta Solutions AB

Authorized purpose: The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model: Synergy and Harmony include conventional and fractionated delivery; Infinity and Harmony Pro add SBRT/SABR; Versa HD and Evo also support SRS and specified functional disorders.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2026-01-15
FDA-cleared K212218

Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB

Authorized purpose: Advanced Algorithms for Treatment Management Applications provides the cleared radiotherapy treatment-management functions described in K212218 for supported treatment-planning inputs and anatomy under qualified professional review.

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