FDA applicant

Image Analysis, Inc.

Columbia, KY10 decisions1985–20170 recalls

FDA records 10 decisions for Image Analysis, Inc. (Columbia, KY) from 1985 to 2017: 10 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Image Analysis Limited”.

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 Image Analysis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Image Analysis, 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 “Image”

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

Image-Guided Neurologics, Inc. 22 Image Data Corp. 6 Image Systems, Inc. 3 Image Diagnostics, Inc. 3 Image Stream Medical, Inc. 2 Image Diagnost International GmbH 2 Image Instruments GmbH 1 Image of Hawaii 1 Image Premastering Services, Inc. 1 Image Enhancements 1 Image Medical, Inc. 1 Image Technology, Inc. 1

Image Analysis, 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 “Image”