FDA applicant

Amicas, Inc.

Boston, MA4 decisions2002–200813 recalls

FDA records 4 decisions for Amicas, Inc. (Boston, MA) from 2002 to 2008: 4 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 3 of them its own earlier devices. 13 recalls are 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 Amicas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2017

2007high 10 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Amicas, 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?

What has been recalled?