Canon Medical Components U.S.A., Inc.
Irvine, CA, US
Canon Medical Components U.S.A., Inc. appears in FDA device records in Irvine, CA. FDA records list 48 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Canon Medical Components U.S.A., Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Canon USA, Inc.510(k), recall
510(k) clearance history
FDA records hold 48 510(k) clearances for Canon Medical Components U.S.A., Inc. between 1984 and 2009. The busiest year on record is 1985, with 6. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 4 |
| 1985 | 6 |
| 1986 | 5 |
| 1987 | 4 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1994 | 6 |
| 1995 | 3 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 3 |
| 2003 | 3 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT | MQB | Substantially Equivalent | |
| K033624 | PACS SOFTWARE SOLUTION 2003 | LLZ | Substantially Equivalent | |
| K031633 | CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C | MQB | Substantially Equivalent | |
| K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI | HKI | Substantially Equivalent | |
| K023750 | CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G | MQB | Substantially Equivalent | |
| K023586 | DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS | MQB | Substantially Equivalent | |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | IXK | Substantially Equivalent | |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | HLI | Substantially Equivalent | |
| K992547 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 | MQB | Substantially Equivalent | |
| K981556 | CANON X-RAY DIGITAL CAMERA CXDI-11 | MQB | Substantially Equivalent | |
| K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | HKI | Substantially Equivalent | |
| K963079 | CANON TX-10 TONOMETER | HKX | Substantially Equivalent | |
| K941234 | NON-MYDRIATIC RETINAL CAMERA | HKI | Substantially Equivalent | |
| K946058 | 60 FUNDUS CAMERA CF-60UV | HKI | Substantially Equivalent | |
| K945635 | TRANS X-1000 | KPX | Substantially Equivalent | |
| K936205 | COMPREHENSIVE PHOROPTER, MDR-680 | HKN | Substantially Equivalent | |
| K936200 | WIRELESS CHART PROJECTOR,HCP-W 721 | HOS | Substantially Equivalent | |
| K936199 | AUTOMATIC LENSOMETER | HLM | Substantially Equivalent | |
| K936209 | SLIT LAMP, H-201 | HJO | Substantially Equivalent | |
| K934663 | 60 DEGREE FUNDUS CAMERA, CF-60UD | HKI | Substantially Equivalent | |
| K925304 | AUTOREF LENSMETER RL-10 | HKO | Substantially Equivalent | |
| K911439 | NON-MYDRIATIC RETINAL CAMERA, CR-45UAF | HKI | Substantially Equivalent | |
| K901839 | 60 FUNDUS CAMERA CF-60UV | HJI | Substantially Equivalent | |
| K895475 | CANON AUTO REF-KERATOMETER RK-2 | HLQ | Substantially Equivalent | |
| K895474 | NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL | HKI | Substantially Equivalent | |
| K891225 | OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 | IYO | Substantially Equivalent | |
| K881889 | CANON IOL ESTIMATOR KU-1 | IYO | Substantially Equivalent | |
| K883200 | CANON AUTOREFRACTOMETER R-22 | HKO | Substantially Equivalent | |
| K882287 | CANON AUTOREFRACTOMETER R-20 | HKO | Substantially Equivalent | |
| K874017 | MODIFIED RETINAL CAMERA MODEL CR4-45NM | HKI | Substantially Equivalent | |
| K871936 | CANON SURGICAL AUTO KERATOMETER SK-1 | HLQ | Substantially Equivalent | |
| K871119 | CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D | JAA | Substantially Equivalent | |
| K870048 | ADDITIONAL MODEL TO CANON UNIVERSAL STAND | KPX | Substantially Equivalent | |
| K862323 | CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM | HKI | Substantially Equivalent | |
| K862575 | UNIVERSAL STAND FOR FILM CHANGER | KPX | Substantially Equivalent | |
| K861416 | CANON AUTO ACUITOMETER CV-10 | HOX | Substantially Equivalent | |
| K861415 | CANON AUTO REF KERATOMETER RK-1 | Substantially Equivalent | ||
| K855170 | CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM | HKI | Substantially Equivalent | |
| K853928 | UNIVERSAL STAND FOR FILM CHANGER | KPX | Substantially Equivalent | |
| K853861 | CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 | IJZ | Substantially Equivalent | |
| K853984 | CANON X-RAY IMAGE DISTRIBUTOR | JAA | Substantially Equivalent | |
| K853983 | CANON X-RAY 35MM CINE CAMERA CSI-35 | IZJ | Substantially Equivalent | |
| K851067 | CANON X-RAY FILM CHANGER CFC-U1 | KPX | Substantially Equivalent | |
| K844898 | CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM | HKI | Substantially Equivalent | |
| K844054 | CANON AUTO KERATOMETER K-1 | HLI | Substantially Equivalent | |
| K844053 | CANON 60 DEGREE FUNDUS CAMERA CF-60S | HFI | Substantially Equivalent | |
| K843021 | CANON 60 FUNDUS CAMERA CF-60U | HKI | Substantially Equivalent | |
| K841861 | CANON AUTOREF R-10 | HKO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017088497 | 3017088497 | Canon Medical Components U.S.A., Inc. | 2355 Main Street, Ste. 150, Irvine, CA 92614 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HKICamera, Ophthalmic, Ac-Powered
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot
- KPXChanger, Radiographic Film/Cassette
- HOXChart, Visual Acuity
- HFICoagulator, Culdoscopic (And Accessories)
- HLMInstrument, Measuring, Lens, Ac-Powered
- HLQKeratoscope, Ac-Powered
- HJILens, Fundus, Hruby, Diagnostic
- IJZOil, Clearing
- HLIOphthalmoscope, Ac-Powered
- HOSProjector, Ophthalmic
- HKORefractometer, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- LLZSystem, Image Processing, Radiological
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IXKSystem, Imaging, X-Ray, Electrostatic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- HKXTonometer, Ac-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0905-03 | Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx | Imaging archive system software mismatches images and patient names. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain