Canon Inc.
Kawasaki Kanagawa, JP
CANON INC. appears in FDA device records in Kawasaki Kanagawa, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000181430 | 1000181430 | CANON INC. | 9-1,Imaikami-cho, Nakahara-ku, Kawasaki Kanagawa 211-8501 JP | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HKICamera, Ophthalmic, Ac-Powered
- LMBDevice, Digital Image Storage, Radiological
- OWBInterventional Fluoroscopic X-Ray System
- HLIOphthalmoscope, Ac-Powered
- HKORefractometer, Ophthalmic
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- NFJSystem, Image Management, Ophthalmic
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- OBOTomography, Optical Coherence
- HKXTonometer, Ac-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1404-2013 | Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye. | Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability. | Class II | Terminated | |
| Z-2265-2012 | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain