510(k) Report

FDA applicant

Nucletron Mfg. Corp.

Urbana, VA1 decision1993–19930 recalls

FDA records 1 decision for Nucletron Mfg. Corp. (Urbana, VA) in 1993: 1 510(k) clearance. All are in product code KPQ (System, Simulation, Radiation Therapy). No recall is 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 Nucletron Mfg. Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nucletron Mfg. Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Nucletron”

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