FDA applicant

Standard Imaging, Inc.

Middleton, WI10 decisions1992–20100 recalls

FDA records 10 decisions for Standard Imaging, Inc. (Middleton, WI) from 1992 to 2010: 10 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and IYE (Accelerator, Linear, Medical). Its devices cite 13 predicates, 2 of them its own earlier devices. 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 Standard Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Standard Imaging, Inc.’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 “Standard”

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

Standard Textile Co., Inc. 23 Standard Bariatrics 12 Standard Diagnostics, Inc. 3 Standard Welders Supply Co. 3 The Standard Co., Ltd. 2 Standard Surgical 1 Standard Engineering 1 Standard Scientific, Inc. 1

Standard Imaging, Inc.

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?

Other applicant names beginning “Standard”