Medical Device Manufacturer · US , Mchenry , IL

Canon USA, Inc.

48 submissions · 48 cleared · Since 1984
48
Total
48
Cleared
0
Denied

Canon USA, Inc. — FDA 510(k) Submissions

Canon USA, Inc. has submitted 48 FDA 510(k) premarket notifications since 1984, of which 48 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Camera, Ophthalmic, Ac-powered, Solid State X-ray Imager (flat Panel/digital Imager), Changer, Radiographic Film/cassette, Refractometer, Ophthalmic, System, Imaging, Pulsed Echo, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623 · MQB Solid State X-ray Imager... · Radiology
Mar 2009 15d
PACS SOFTWARE SOLUTION 2003
K033624 · LLZ System, Image Processing,... · Radiology
Dec 2003 27d
CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C
K031633 · MQB Solid State X-ray Imager... · Radiology
Jun 2003 15d
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · HKI Camera, Ophthalmic,... · Ophthalmic
Jun 2003 10d
CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G
K023750 · MQB Solid State X-ray Imager... · Radiology
Nov 2002 14d
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · MQB Solid State X-ray Imager... · Radiology
Nov 2002 11d
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689 · IXK System, Imaging, X-ray,... · Radiology
Jan 2002 398d
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606 · HLI Ophthalmoscope, Ac-powered · Ophthalmic
Jun 2000 323d
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547 · MQB Solid State X-ray Imager... · Radiology
Oct 1999 75d
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556 · MQB Solid State X-ray Imager... · Radiology
Nov 1998 187d
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246 · HKI Camera, Ophthalmic,... · Ophthalmic
May 1998 103d
CANON TX-10 TONOMETER
K963079 · HKX Tonometer, Ac-powered · Ophthalmic
Mar 1997 208d
NON-MYDRIATIC RETINAL CAMERA
K941234 · HKI Camera, Ophthalmic,... · Ophthalmic
Jun 1995 449d
60 FUNDUS CAMERA CF-60UV
K946058 · HKI Camera, Ophthalmic,... · Ophthalmic
Feb 1995 87d
TRANS X-1000
K945635 · KPX Changer, Radiographic... · Radiology
Feb 1995 77d
AUTOMATIC LENSOMETER
K936199 · HLM Instrument, Measuring,... · Ophthalmic
Sep 1994 273d
WIRELESS CHART PROJECTOR,HCP-W 721
K936200 · HOS Projector, Ophthalmic · Ophthalmic
Sep 1994 273d
COMPREHENSIVE PHOROPTER, MDR-680
K936205 · HKN Refractor, Manual,... · Ophthalmic
Sep 1994 273d
SLIT LAMP, H-201
K936209 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic
Apr 1994 93d
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · HKI Camera, Ophthalmic,... · Ophthalmic
Feb 1994 147d
AUTOREF LENSMETER RL-10
K925304 · HKO Refractometer, Ophthalmic · Ophthalmic
Feb 1994 484d
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · HKI Camera, Ophthalmic,... · Ophthalmic
Jun 1991 76d
60 FUNDUS CAMERA CF-60UV
K901839 · HJI Lens, Fundus, Hruby,... · Ophthalmic
Jul 1990 72d
CANON AUTO REF-KERATOMETER RK-2
K895475 · HLQ Keratoscope, Ac-powered · Ophthalmic
Oct 1989 50d
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · HKI Camera, Ophthalmic,... · Ophthalmic
Oct 1989 23d
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