510(k) Report

FDA applicant

Imaging Engineering, LLC

Cape Coral, FL4 decisions2019–20250 recalls

FDA records 4 decisions for Imaging Engineering, LLC (Cape Coral, FL) from 2019 to 2025: 4 510(k) clearances. All are in product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Since 2016 its 510(k)s took a median of 26 days from receipt to decision, against 49 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Imaging Engineering, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12020: 12021: 12025: 1
2019high 1 (2019) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Imaging Engineering, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 26 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 49 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191310Insight Essentials DRF Digital Imaging SystemImaging Engineering, LLC · 20191cites it
  • K210469Insight Agile DRFImaging Engineering, LLC · 20211cites it
  • K200396Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC · 20201cites it

What has FDA decided for it lately?

  • K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025
  • K210469Insight Agile DRFImaging Engineering, LLC · 2021
  • K200396Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC · 2020
  • K191310Insight Essentials DRF Digital Imaging SystemImaging Engineering, LLC · 2019

All 4 as Imaging Engineering, LLC →

Other applicant names beginning “Imaging”

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

Imaging Dynamics Company, Ltd. 21Imaging Sciences Intl., Inc. 7Imaging Biometrics, LLC 4Imaging Sciences International 3Imaging Therapeutics, Inc. 2Imaging Services, Inc. 2Imaging Accessories, Inc. 2Imaging Wave, LLC 1Imaging and X-Ray Intl., Inc. 1Imaging Sciences International (Dba Gendex, LLC) 1Imaging Sciences International /Gendex/Dexis 1Imaging Concepts, Inc. 1