# Elekta Solutions AB

- Location (FDA's records): Stockholm, SE
- FDA decisions: 15 (2020–2026): 15 510(k) clearances
- Product codes: IYE (5), MUJ (4), IWB (3), QKB (1), LLZ (1), HAW (1)
- 510(k) review time since 2016: median 129 days, against 129 for FDA's reviews in the same codes and years (7 of 12 faster)
- Predicates its devices cite: 17 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Elekta, Ltd.: 4 (https://510kreport.com/company/elekta)
- Elekta Instrument AB: 4 (https://510kreport.com/company/elekta-instrument)
- Mirada Medical, Ltd.: 1 (https://510kreport.com/company/mirada-medical)
- RaySearch Laboratories AB (PUBL): 1 (https://510kreport.com/company/raysearch-laboratories-ab-publ)
- Proknow, LLC: 1 (https://510kreport.com/company/proknow)

## Firms that cite its devices most
- Prowess, Inc.: 1 (https://510kreport.com/company/prowess)
- RaySearch Laboratories AB (PUBL): 1 (https://510kreport.com/company/raysearch-laboratories-ab-publ)

## Its most-cited devices
- K203172: MOSAIQ Oncology Information System (2020), cited by 3
- K222047: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (2022), cited by 1
- K223233: Monaco RTP System (2023), cited by 1
- K213787: Monaco RTP System (2022), cited by 1
- K202789: Monaco Rtp System (2021), cited by 1
- K212114: Elekta Unity (2021), cited by 1

## Recent decisions
- K261932: Leksell® Vantage Stereotactic System (Aug 5, 2026)
- K252002: Monaco RTP System (6.3) (Feb 19, 2026)
- K252188: EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (Jan 15, 2026)
- K251363: ProKnow DS (Oct 8, 2025)
- K250391: Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) (Jul 2, 2025)
- K232854: Leksell GammaPlan (LGP) (Feb 8, 2024)
- K223209: Elekta Unity (Feb 23, 2023)
- K223229: MOSAIQ® OIS (Oncology Information System) (Feb 23, 2023)

Source page: https://510kreport.com/company/elekta-solutions