ClearanceBrief
Company · SE

Elekta Solutions AB

FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (3 in 12 months)
2recalls (1 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYEAccelerator, Linear, Medical7
MUJSystem, Planning, Radiation Therapy Treatment4
IWBSystem, Radiation Therapy, Radionuclide3
HAWNeurological Stereotaxic Instrument1
LLZSystem, Image Processing, Radiological1
QKBRadiological Image Processing Software For Radiation Therapy1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 5, 2026K261932Leksell® Vantage Stereotactic System
Elekta Solutions AB, SE
HAW
Feb 19, 2026K252002Monaco RTP System (6.3)
Elekta Solutions AB, SE
MUJ
Jan 15, 2026K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekt
Elekta Solutions AB, SE
IYE
Oct 8, 2025K251363ProKnow DS
Elekta Solutions AB, SE
LLZ
Jul 2, 2025K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)
Elekta Solutions AB, SE
IWB
Feb 8, 2024K232854Leksell GammaPlan (LGP)
Elekta Solutions AB, SE
IWB
Feb 23, 2023K223233Monaco RTP System
Elekta Solutions AB, SE
MUJ
Feb 23, 2023K223229MOSAIQ® OIS (Oncology Information System)
Elekta Solutions AB, SE
IYE
Feb 23, 2023K223209Elekta Unity
Elekta Solutions AB, SE
IYE
Oct 26, 2022K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Elekta Solutions AB, SE
IWB
May 17, 2022K213787Monaco RTP System
Elekta Solutions AB, SE
MUJ
Oct 25, 2021K212218Advanced Algorithms for Treatment Management Applications (AATMA)
Elekta Solutions AB, SE
QKB
Oct 1, 2021K212114Elekta Unity
Elekta Solutions AB, SE
IYE
Feb 23, 2021K202789Monaco Rtp System
Elekta Solutions AB, SE
MUJ
Dec 18, 2020K203172MOSAIQ Oncology Information System
Elekta Solutions AB, SE
IYE

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 14, 2025ELEKTA SOLUTIONS AB
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (0
Open, Classified		 IYEK223229
Sep 28, 2021ELEKTA SOLUTIONS AB
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Terminated		 IYEK210500
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