510(k) Report

FDA applicant

Thermotrex Corp.

Danbury, CT1 decision1996–19960 recalls

FDA records 1 decision for Thermotrex Corp. (Danbury, CT) in 1996: 1 510(k) clearance. All are in product code IXJ (Grid, Radiographic). 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 Thermotrex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermotrex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Thermotrex Corp.’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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