510(k) Report

FDA applicant

Ix-Dr, Inc.

Howell, MI1 decision2003–20030 recalls

FDA records 1 decision for Ix-Dr, Inc. (Howell, MI) in 2003: 1 510(k) clearance. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Ix-Dr, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ix-Dr, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ix-Dr, 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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