FDA applicant

Lightlab Imaging, Inc.

Westford, MA10 decisions2010–20160 recalls

FDA records 10 decisions for Lightlab Imaging, Inc. (Westford, MA) from 2010 to 2016: 10 510(k) clearances. Most are in product codes NQQ (System, Imaging, Optical Coherence Tomography…) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 13 predicates, 9 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 Lightlab Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010high 4 (2015) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Lightlab Imaging, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Lightlab Imaging, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?