510(k) Report

FDA applicant

Elekta, Ltd.

Crawley, GB22 decisions2005–202156 recalls

FDA records 22 decisions for Elekta, Ltd. (Crawley, GB) from 2005 to 2021: 22 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 58 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 12 of them its own earlier devices. 56 recalls are linked to its devices.

FDA’s records also spell it “Elekta Limited”, “Elekta, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Elekta, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 22010: 22011: 22012: 32013: 22014: 12015: 12018: 32019: 32021: 1
2007high 3 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 12008: 12010: 22011: 52012: 52013: 102015: 12016: 12017: 32019: 102020: 32021: 62023: 72025: 1
2007high 10 (2013) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Elekta, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elekta, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical19decisions
  • MUJSystem, Planning, Radiation Therapy Treatment2decisions
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 86 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 58 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 36 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131965XVI R5.0Elekta Limited · 20133cite it
  • K051932Elekta Synergy; Elekta Synergy S and XVIR3.5Elekta, Inc. · 20053cite it
  • K123808AgilityElekta, Ltd. · 20132cite it
  • K183034MOSAIQ Oncology Information SystemElekta, Inc. · 20182cite it
  • K192482Elekta UnityElekta Limited · 20191cites it
  • K082122MLCI2Elekta, Ltd. · 20081cites it

What has FDA decided for it lately?

  • K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 202110 recalls
  • K192482Elekta UnityElekta Limited · 20193 recalls
  • K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019
  • K190178Monaco RTP SystemElekta, Inc. · 20195 recalls
  • K183037Monaco RTP SystemElekta, Inc. · 20186 recalls
  • K183034MOSAIQ Oncology Information SystemElekta, Inc. · 20182 recalls
  • K182076Elekta UnityElekta Limited · 20184 recalls
  • K153011iViewDose R1.0Elekta Limited · 2015

All 10 as Elekta, Ltd. →All 8 as Elekta Limited →All 4 as Elekta, Inc. →

What has been recalled?

56 recalls linked to its devices; the latest:

  • K210500Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta…Dec 14, 2025Class II
  • K210500ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle…Oct 25, 2023Class II
  • K210500ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle…Oct 25, 2023Class II
  • K210500ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy…Oct 25, 2023Class II
  • K210500ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical…Oct 25, 2023Class II
  • K210500ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy…Oct 25, 2023Class II

Other applicant names beginning “Elekta”

FDA records each applicant name separately; these may or may not be the same firm.

Elekta Instrument AB 35Elekta Solutions AB 15Elekta Instruments, Inc. 8Elekta Oncology Systems, Ltd. 5Elekta Neuromag OY 4Elekta Implants, SA 2Elekta Radiosurgery, Inc. 1Elekta Inc. D/B/A Nucletron Corporation 1