FDA applicant

Ziehm-Orthoscan, Inc.

Scottsdale, AZ3 decisions2025–20261 recall

FDA records 3 decisions for Ziehm-Orthoscan, Inc. (Scottsdale, AZ) from 2025 to 2026: 3 510(k) clearances. All are in product code OXO (Image-Intensified Fluoroscopic X-Ray System…). Its devices cite 6 predicates, 2 of them its own earlier devices. 1 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 Ziehm-Orthoscan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025high 1 (2026) · low 0 (2025)2026

Class I Class II/III not classified

FIG. 1 — Ziehm-Orthoscan, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ziehm-Orthoscan, 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 “Ziehm-Orthoscan”

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

Ziehm Imaging GmbH 25 Ziehm International, Inc. 16

Ziehm-Orthoscan, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Ziehm-Orthoscan”