FDA applicant

Elekta Oncology Systems, Ltd.

Norcross, GA5 decisions1997–20037 recalls

FDA records 5 decisions for Elekta Oncology Systems, Ltd. (Norcross, GA) from 1997 to 2003: 5 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 2 predicates, 1 of them its own earlier devices. 7 recalls are linked to its devices.

FDA’s records also spell it “Elekta Oncology Systems, 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 Oncology Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elekta Oncology Systems, Ltd. since 2007.

Recalls per year

1in 2013

2007high 1 (2007) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Elekta Oncology Systems, 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

Other applicant names beginning “Elekta”

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

Elekta Instrument AB 35 Elekta, Ltd. 22 Elekta Solutions AB 15 Elekta Instruments, Inc. 8 Elekta Neuromag OY 4 Elekta Implants, SA 2 Elekta Radiosurgery, Inc. 1 Elekta Inc. D/B/A Nucletron Corporation 1

Elekta Oncology Systems, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Elekta”