FDA applicant

Image of Hawaii

Waianae, HI1 decision1987–19870 recalls

FDA records 1 decision for Image of Hawaii (Waianae, HI) in 1987: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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, ophthalmic panel, where it files most

How often FDA has decided Image of Hawaii’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Image of Hawaii since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Image of Hawaii 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”

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

Image-Guided Neurologics, Inc. 22 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 Premastering Services, Inc. 1 Image Enhancements 1 Image Medical, Inc. 1 Image Technology, Inc. 1

Image of Hawaii

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Image”