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Canon USA, Inc.

Country not established

Devices
48
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Canon USA, Inc. makes

Canon USA, Inc. manufactures diagnostic imaging equipment, including X-ray image distributors and digital X-ray cameras (such as the CXDI-40C and CXDI-11), a fundus camera for retinal imaging (CF-60U), and a laser blood flowmeter (CLBF Model 100). Their portfolio also includes ophthalmic devices like an auto acuitymeter (CV-10) and an intraocular lens estimator probe (KU-1), alongside PACS software solutions for medical imaging data management and a rapid sequence X-ray camera (CRS-105). Additional products include a universal stand for film changers and a digital radiography system for medical diagnostics.

These devices are regulated under FDA 510(k) clearance requirements, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) database, reflecting their authorised status for distribution in the United States. Canon USA, Inc. is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue48

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FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Canon USA, Inc., initiated on 2003-03-11. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2003

    • 11 Mar 2003 Z-0905-03 Unclassified (pre-2012) Terminated Imaging archive system software mismatches images and patient names. Distribution: States of IA, CA , AR, WA, OR

Frequently asked questions

How many devices does Canon USA, Inc. have in the registry?

The registry currently lists 48 devices for Canon USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Canon USA, Inc.'s devices?

Among its 48 most recently registered devices, Canon USA, Inc. has devices listed in FDA 510(k) (48 devices).

What risk classes do Canon USA, Inc.'s devices fall under?

Among its 48 most recently registered devices, the classes recorded for Canon USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Canon USA, Inc.?

FDA recall records list 1 recall initiated by Canon USA, Inc., the most recent initiated on 2003-03-11. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Canon USA, Inc. in the registry?

The most recently registered devices listed for Canon USA, Inc. include CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D, CANON 60 FUNDUS CAMERA CF-60U, CANON X-RAY IMAGE DISTRIBUTOR and OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1.

Generated automatically from registry data and not verified by a human reviewer.