510(k) Report

FDA applicant

Imagelabs, Inc.

Bedford, MA1 decision1996–19960 recalls

FDA records 1 decision for Imagelabs, Inc. (Bedford, MA) in 1996: 1 510(k) clearance. All are in product code LMD (System, Digital Image Communications…). Its devices cite 1 predicate, 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 Imagelabs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Imagelabs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Imagelabs, 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?

  • LMDSystem, Digital Image Communications, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K961753Shared Vision (Part Number SV 0015)Imagelabs, Inc. · 1996

The one decision as Imagelabs, Inc. →