510(k) Report

FDA applicant

Elekta Instrument AB

Stockholm, SE35 decisions1996–201924 recalls

FDA records 35 decisions for Elekta Instrument AB (Stockholm, SE) from 1996 to 2019: 35 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and IWB (System, Radiation Therapy, Radionuclide). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 55 predicates, 29 of them its own earlier devices. 24 recalls are linked to its devices, 2 Class I.

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 Instrument AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 12008: 12009: 32010: 12012: 12014: 12015: 32016: 22017: 12018: 22019: 1
2007high 3 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 32008: 12009: 22010: 12011: 12014: 12015: 12016: 12017: 12018: 12020: 22023: 12024: 2, 2 Class I2025: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2012)2026

Class I Class II/III not classified

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

Planning a device like Elekta Instrument AB’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?

  • HAWNeurological Stereotaxic Instrument16decisions
  • IWBSystem, Radiation Therapy, Radionuclide13decisions
  • MUJSystem, Planning, Radiation Therapy Treatment4decisions
  • IYEAccelerator, Linear, Medical2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 55 predicates; 29 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 49 times; 29 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.

  • K960338Stereotactic Body FrameElekta Instrument AB · 19965cite it
  • K972324Leksell Stereotactic SystemElekta Instrument AB · 19983cite it
  • K970291Accessories to the Stereotactic Body FramElekta Instrument AB · 19972cite it
  • K080355Leksell Stereotactic System with Reusable Fixation ScrewsElekta Instrument AB · 20092cite it
  • K061941Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 20062cite it
  • K190887Leksell Vantage Stereotactic SystemElekta Instrument AB · 20192cite it

What has FDA decided for it lately?

  • K190887Leksell Vantage Stereotactic SystemElekta Instrument AB · 20193 recalls
  • K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
  • K173791Leksell GammaPlanElekta Instrument AB · 20182 recalls
  • K171123Leksell Vantage Stereotactic SystemElekta Instrument AB · 20172 recalls
  • K160440Leksell Gamma Knife IconElekta Instrument AB · 20161 recall
  • K152558Leksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB · 20162 Class I recalls
  • K151159Leksell Gamma Knife PerfexionElekta Instrument AB · 20151 recall
  • K151666Leksell GammaPlanElekta Instrument AB · 20151 recall

All 35 as Elekta Instrument AB →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K190887Brand Name: Leksell Vantage Arc System REF: 1053958Mar 19, 2026Class II
  • K173791Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…Dec 12, 2025Class II
  • K151666Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…Dec 12, 2025Class II
  • K190887Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic…Sep 30, 2025Class II
  • K152558Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933…Sep 25, 2024Class I
  • K152558Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm…Mar 15, 2024Class I

Other applicant names beginning “Elekta”

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

Elekta, Ltd. 22Elekta 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