FDA applicant

Intuitive Imaging Informatics, LLC

Bell Canyon, CA3 decisions2003–20130 recalls

FDA records 3 decisions for Intuitive Imaging Informatics, LLC (Bell Canyon, CA) from 2003 to 2013: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 6 predicates, 1 of them its own earlier devices. 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 Intuitive Imaging Informatics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Intuitive Imaging Informatics, LLC’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 “Intuitive”

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

Intuitive Surgical, Inc. 198 Intuitive Spine, LLC 1 Intuitive Surgical Operations, Inc. 1

Intuitive Imaging Informatics, LLC

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?

Other applicant names beginning “Intuitive”