Elekta Solutions AB
Elekta Solutions AB holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Elekta Solutions AB
FDA recalls by Elekta Solutions AB
- Z-0503-2026 — 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 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
- Z-0115-2022 — Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Elekta Solutions AB
- K261932 — Leksell® Vantage Stereotactic System
- K252002 — Monaco RTP System (6.3)
- K252188 — EMLA (6 models)
- K251363 — ProKnow DS
- K250391 — Leksell Gamma Knife® (3 models)
- K232854 — Leksell GammaPlan (LGP)
- K223209 — Elekta Unity
- K223229 — MOSAIQ® OIS (Oncology Information System)
- K223233 — Monaco RTP System
- K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
- K213787 — Monaco RTP System
- K212218 — Advanced Algorithms for Treatment Management Applications (AATMA)
- K212114 — Elekta Unity
- K202789 — Monaco Rtp System
- K203172 — MOSAIQ Oncology Information System
Data sourced from openFDA. This site is unofficial and independent of the FDA.