FDA applicant

Imaging Sciences International /Gendex/Dexis

Hatfield, PA1 decision2015–20150 recalls

FDA records 1 decision for Imaging Sciences International /Gendex/Dexis (Hatfield, PA) in 2015: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 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 Imaging Sciences International /Gendex/Dexis’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Imaging Sciences International /Gendex/Dexis by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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 Sciences International 3 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 Concepts, Inc. 1

Imaging Sciences International /Gendex/Dexis

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Imaging”