FDA applicant

Imris, Inc.

Rockville, MD14 decisions2006–201512 recalls

FDA records 14 decisions for Imris, Inc. (Rockville, MD) from 2006 to 2015: 14 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and HBL (Holder, Head, Neurosurgical (Skull Clamp)). Its devices cite 22 predicates, 11 of them its own earlier devices. 12 recalls are linked to its devices, 4 Class I.

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 Imris, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 3 (2012) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

5in 2025

2007high 5 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Imris, 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 “Imris”

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

Imris Imaging, Inc. 1

Imris, 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?

Other applicant names beginning “Imris”