510(k) Report

FDA applicant

Source Production & Equipment Co., Inc.

Saint Rose, LA3 decisions2006–20141 recall

FDA records 3 decisions for Source Production & Equipment Co., Inc. (Saint Rose, LA) from 2006 to 2014: 3 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and JAQ (System, Applicator, Radionuclide…). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 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 Source Production & Equipment Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 12014: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Source Production & Equipment Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Source”

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