Elekta Solutions AB

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Elekta Solutions AB on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-02-19	K252002	Monaco RTP System (6.3)	Elekta Solutions AB	Radiology
2026-01-15	K252188	EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)	Elekta Solutions AB	Radiology
2021-10-25	K212218	Advanced Algorithms for Treatment Management Applications (AATMA)	Elekta Solutions AB	Radiology

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