FDA applicant

Image Systems, Inc.

San Leandro, CA3 decisions1985–19910 recalls

FDA records 3 decisions for Image Systems, Inc. (San Leandro, CA) from 1985 to 1991: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LHQ (System, Telethermographic (Adjunctive Use)). 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 Image Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Image Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Image Systems, 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”

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 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 Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Image”