FDA applicant

Automated Imaging Diagnostics, LLC

Gainesville, FL1 decision2026–20260 recalls

FDA records 1 decision for Automated Imaging Diagnostics, LLC (Gainesville, FL) in 2026: 1 De Novo grant. All are in product code SHO (Parkinsonian Syndrome Diagnostic Aid). 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, neurology panel, where it files most

How often FDA has decided Automated Imaging Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Other applicant names beginning “Automated”

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

Automated Medical Products Corp. 6 Automated Screening Devices 2 Automated IV Systems, Inc. 1 Automated Ophthalmics, Inc. 1 Automated Testing Services, Ltd. 1 Automated Lens System 1

Automated Imaging Diagnostics, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Automated”