510(k) Report

FDA applicant

Digivision, Inc.

North Attleboro, MA4 decisions1986–19960 recalls

FDA records 4 decisions for Digivision, Inc. (North Attleboro, MA) from 1986 to 1996: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 1 predicate, 1 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 Digivision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digivision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Digivision, 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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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological3decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K962260Real-Time Video Contrast EnhancerDigivision, Inc. · 19961cites it
  • K864584Fluorovision Contrast EnhancerDigivision, Inc. · 19861cites it

What has FDA decided for it lately?

  • K962260Real-Time Video Contrast EnhancerDigivision, Inc. · 1996
  • K895320Fluorovision HR 2000 High Resolution Image EnhanceDigivision, Inc. · 1989
  • K873646DigiviewerDigivision, Inc. · 1987
  • K864584Fluorovision Contrast EnhancerDigivision, Inc. · 1986

All 4 as Digivision, Inc. →