FDA applicant

Turner Imaging Systems, Inc.

Orem, UT1 decision2019–20190 recalls

FDA records 1 decision for Turner Imaging Systems, Inc. (Orem, UT) in 2019: 1 510(k) clearance. All are in product code OXO (Image-Intensified Fluoroscopic X-Ray System…). 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 Turner Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Turner Imaging Systems, 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 “Turner”

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

Turner Assoc. 3 Turner Designs, Inc. 2

Turner Imaging Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Turner”