510(k) Report

FDA applicant

Xri, Inc.

Tustin, CA1 decision1994–19940 recalls

FDA records 1 decision for Xri, Inc. (Tustin, CA) in 1994: 1 510(k) clearance. All are in product code IYB (Tube Mount, X-Ray, Diagnostic). 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 Xri, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Xri, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Xri, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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