FDA applicant

Elekta Inc. D/B/A Nucletron Corporation

Baltimore, MD1 decision2012–20123 recalls

FDA records 1 decision for Elekta Inc. D/B/A Nucletron Corporation (Baltimore, MD) in 2012: 1 510(k) clearance. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 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, radiology panel, where it files most

How often FDA has decided Elekta Inc. D/B/A Nucletron Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2012high 2 (2015) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Elekta Inc. D/B/A Nucletron Corporation by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elekta Inc. D/B/A Nucletron Corporation’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 Oncology Systems, Ltd. 5 Elekta Neuromag OY 4 Elekta Implants, SA 2 Elekta Radiosurgery, Inc. 1

Elekta Inc. D/B/A Nucletron Corporation

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”