FDA applicant

Image-Guided Neurologics, Inc.

Melbourne, FL22 decisions1999–20053 recalls

FDA records 22 decisions for Image-Guided Neurologics, Inc. (Melbourne, FL) from 1999 to 2005: 22 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and LNH (System, Nuclear Magnetic Resonance Imaging). 3 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, neurology panel, where it files most

How often FDA has decided Image-Guided Neurologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Image-Guided Neurologics, Inc. since 2007.

Recalls per year

1in 2021

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Image-Guided”

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

Image Analysis, Inc. 10 Image Data Corp. 6 Image Systems, Inc. 3 Image Diagnostics, Inc. 3 Image Stream Medical, Inc. 2 Image Diagnost International GmbH 2 Image Instruments GmbH 1 Image of Hawaii 1 Image Premastering Services, Inc. 1 Image Enhancements 1 Image Medical, Inc. 1 Image Technology, Inc. 1

Image-Guided Neurologics, Inc.

Which product codes does it file in?

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 “Image-Guided”