FDA applicant

Ophthalmic Imaging Systems

Sacramento, CA5 decisions1991–20117 recalls

FDA records 5 decisions for Ophthalmic Imaging Systems (Sacramento, CA) from 1991 to 2011: 5 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and HLI (Ophthalmoscope, Ac-Powered). Its devices cite 8 predicates, 1 of them its own earlier devices. 7 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, ophthalmic panel, where it files most

How often FDA has decided Ophthalmic Imaging Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 5 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Ophthalmic”

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

Ophthalmic Technologies, Inc. 9 Ophthalmic Consultants, Inc. 2 Ophthalmic Resources, Inc. 1 Ophthalmic Solutions, LLC 1 Ophthalmic Labs, Inc. 1

Ophthalmic Imaging Systems

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 “Ophthalmic”