510(k) Report

FDA applicant

Elekta Instruments, Inc.

Atlanta, GA8 decisions1992–19995 recalls

FDA records 8 decisions for Elekta Instruments, Inc. (Atlanta, GA) from 1992 to 1999: 8 510(k) clearances. Most are in product codes HCH (Clip, Aneurysm) and JAI (Couch, Radiation Therapy, Powered). Its devices cite 6 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Elekta Instruments, Inc. since 2007.

Recalls per year

1in 2015

2007: 12008: 12013: 12015: 1
2007high 1 (2007) · low 0 (2009)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • HCHClip, Aneurysm1decision
  • JAICouch, Radiation Therapy, Powered1decision
  • IWBSystem, Radiation Therapy, Radionuclide1decision
  • HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1decision
  • HRSPlate, Fixation, Bone1decision
  • GXDGenerator, Lesion, Radiofrequency1decision

Also: HAW (1), GEY (1).

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 0 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.

  • K955064Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 19966cite it
  • K946165CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemElekta Instruments, Inc. · 19954cite it
  • K983678Elekta Oncology Systems Precise Treatment TableElekta Instruments, Inc. · 19992cite it
  • K914808Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 19922cite it
  • K943468Leksell SurgiplanElekta Instruments, Inc. · 19952cite it

What has FDA decided for it lately?

  • K983678Elekta Oncology Systems Precise Treatment TableElekta Instruments, Inc. · 19994 recalls
  • K955064Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
  • K941823Leksell Neuro Generator and AccessoriesElekta Instruments, Inc. · 1996
  • K946165CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemElekta Instruments, Inc. · 1995
  • K943468Leksell SurgiplanElekta Instruments, Inc. · 19951 recall
  • K932261ES-100 AccessoriesElekta Instruments, Inc. · 1994
  • K925360ES-100 Power System, ES-100 SeriesElekta Instruments, Inc. · 1993
  • K914808Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992

All 8 as Elekta Instruments, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K983678Elekta Precise Treatment TableJan 29, 2015Class II
  • K983678Precise Treatment Table. To be used as part of radiation therapy treatment process.Mar 14, 2013Class II
  • K983678Precise Treatment Table The Precise Treatment Table is intended as a universal patient…Mar 10, 2008
  • K983678Precise Treatment Table Intended as a universal patient treatment support and…Jan 11, 2007
  • K943468Leksell SurgiPlanMay 23, 2005

Other applicant names beginning “Elekta”

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

Elekta Instrument AB 35Elekta, Ltd. 22Elekta Solutions AB 15Elekta Oncology Systems, Ltd. 5Elekta Neuromag OY 4Elekta Implants, SA 2Elekta Radiosurgery, Inc. 1Elekta Inc. D/B/A Nucletron Corporation 1