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ELEKTA SOLUTIONS AB

Sweden·SE-MF-000002125

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Leksell GammaPlan 11.5	1577756	EUDAMED	Class IIb	Active
Elekta Unity	K212114	FDA 510(k)	Class II	Active
Advanced Algorithms for Treatment Management Applications (AATMA)	K212218	FDA 510(k)	Class II	Active
Monaco Rtp System	K202789	FDA 510(k)	Class II	Active
Leksell GammaPlan (LGP)	K232854	FDA 510(k)	Class II	Active
MOSAIQ® OIS (Oncology Information System)	K223229	FDA 510(k)	Class II	Active
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)	K252188	EUDAMEDFDA 510(k)	Class II	Active
ProKnow DS	K251363	FDA 510(k)	Class II	Active
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)	K222047	FDA 510(k)	Class II	Active
MOSAIQ Oncology Information System	K203172	FDA 510(k)	Class II	Active
Monaco RTP System	K223233	EUDAMEDFDA 510(k)	Class II	Active
Monaco RTP System (6.3)	K252002	FDA 510(k)	Class II	Active
Monaco RTP System	K213787	FDA 510(k)	Class II	Active
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)	K250391	FDA 510(k)	Class II	Active
Elekta Unity	K223209	FDA 510(k)	Class II	Active
Kaiku Health	Kaiku Health major version 8	EUDAMED	Class IIa	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 17, 2025	Z-0503-2026	—	open, classified	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.
Sep 28, 2021	Z-0115-2022	—	terminated	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.

Establishments registered with the FDA under this company group, matched by name.