FDA applicant

Imaging Sciences International

Hatfield, PA3 decisions2014–20160 recalls

FDA records 3 decisions for Imaging Sciences International (Hatfield, PA) from 2014 to 2016: 3 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Imaging Sciences International, LLC”.

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 Imaging Sciences International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Imaging Sciences International by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Imaging Sciences International’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 “Imaging”

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

Imaging Dynamics Company, Ltd. 21 Imaging Sciences Intl., Inc. 7 Imaging Engineering, LLC 4 Imaging Biometrics, LLC 4 Imaging Therapeutics, Inc. 2 Imaging Services, Inc. 2 Imaging Accessories, Inc. 2 Imaging Wave, LLC 1 Imaging and X-Ray Intl., Inc. 1 Imaging Sciences International (Dba Gendex, LLC) 1 Imaging Sciences International /Gendex/Dexis 1 Imaging Concepts, Inc. 1

Imaging Sciences International

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 “Imaging”