FDA applicant

Imaging Therapeutics, Inc.

San Mateo, CA2 decisions2003–20080 recalls

FDA records 2 decisions for Imaging Therapeutics, Inc. (San Mateo, CA) from 2003 to 2008: 2 510(k) clearances. Most are in product codes HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing…) and KGI (Densitometer, Bone). Its devices cite 8 predicates, 0 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Imaging Therapeutics, Inc.’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 “Imaging”

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

Imaging Dynamics Company, Ltd. 21 Imaging Sciences Intl., Inc. 7 Imaging Engineering, LLC 4 Imaging Biometrics, LLC 4 Imaging Sciences International 3 Imaging Services, Inc. 2 Imaging Accessories, Inc. 2 Imaging Wave, LLC 1 Imaging and X-Ray Intl., Inc. 1 Imaging Sciences International (Dba Gendex, LLC) 1 Imaging Sciences International /Gendex/Dexis 1 Imaging Concepts, Inc. 1

Imaging Therapeutics, Inc.

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 “Imaging”