FDA applicant

Aurora Imaging Technology, Inc.

North Andover, MA7 decisions2001–20080 recalls

FDA records 7 decisions for Aurora Imaging Technology, Inc. (North Andover, MA) from 2001 to 2008: 7 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 8 predicates, 4 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 Aurora Imaging Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aurora Imaging Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Aurora”

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

Aurora Spine, Inc. 10 Aurora Technology Development, LLC 1 Aurora Technology, Inc. 1

Aurora Imaging Technology, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Aurora”