510(k) Report

FDA applicant

Base Ten Systems, Inc.

Trenton, NJ3 decisions1995–19960 recalls

FDA records 3 decisions for Base Ten Systems, Inc. (Trenton, NJ) from 1995 to 1996: 3 510(k) clearances. Most are in product codes LMB (Device, Digital Image Storage, Radiological) and JQP (Calculator/Data Processing Module, For…). 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 Base Ten Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Base Ten Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LMBDevice, Digital Image Storage, Radiological2decisions
  • JQPCalculator/Data Processing Module, For Clinical Use1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K961160Upacs Version 1.7Base Ten Systems, Inc. · 19962cite it

What has FDA decided for it lately?

  • K961160Upacs Version 1.7Base Ten Systems, Inc. · 1996
  • K960941UPACSBase Ten Systems, Inc. · 1996
  • K953652Prenval IBase Ten Systems, Inc. · 1995

All 3 as Base Ten Systems, Inc. →