510(k) Report

FDA applicant

Perceptive Systems, Inc.

Boulder, CO2 decisions1986–19950 recalls

FDA records 2 decisions for Perceptive Systems, Inc. (Boulder, CO) from 1986 to 1995: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LNJ (Analyzer, Chromosome, Automated). 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 Perceptive Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Perceptive Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Perceptive 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?

  • LLZSystem, Image Processing, Radiological1decision
  • LNJAnalyzer, Chromosome, Automated1decision

What has FDA decided for it lately?

  • K952778CheshirePerceptive Systems, Inc. · 1995
  • K861974Perceptive Systems Inc Psicom 217 Karyotyping SystPerceptive Systems, Inc. · 1986

All 2 as Perceptive Systems, Inc. →

Other applicant names beginning “Perceptive”

FDA records each applicant name separately; these may or may not be the same firm.

Perceptive Software 1