FDA applicant

Schoelly Imaging, Inc.

Framingham, MA5 decisions2006–20090 recalls

FDA records 5 decisions for Schoelly Imaging, Inc. (Framingham, MA) from 2006 to 2009: 5 510(k) clearances. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Its devices cite 6 predicates, 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Schoelly Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Schoelly Imaging, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Schoelly”

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

Schoelly Fiberoptic GmbH 12 Schoelly Technologies, Inc. 2

Schoelly 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 “Schoelly”