510(k) Report

FDA applicant

Howtek, Inc.

Hudson, NH5 decisions1996–20020 recalls

FDA records 5 decisions for Howtek, Inc. (Hudson, NH) from 1996 to 2002: 5 510(k) clearances. Most are in product codes LMA (Digitizer, Image, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 2 predicates, 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 Howtek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Howtek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Howtek, 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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