Canon, Inc.

Medical device manufacturer in Tokyo, JP.

43510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K252503Intelligent NROWB · Traditional 04/30/2026SE
K241049CANON Fundus Camera CR-10 (CR-10)HKI · Special 05/15/2024SE
K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlOWB · Traditional 04/26/2024SE
K230175Digital Radiography CXDI-CS01MQB · Special 02/15/2023SE
K222855Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special 10/17/2022SE
K222687Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special 09/29/2022SE
K222661Digital Radiography CXDI-CS01MQB · Special 09/27/2022SE
K221876Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special 07/15/2022SE
K221620Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special 06/14/2022SE
K220098Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special 02/04/2022SE
K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1MQB · Traditional 01/24/2022SE
K212269Intelligent NRMQB · Traditional 09/17/2021SE
K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1MQB · Special 09/09/2021SE
K203849General Radiography CXDI-CS01MQB · Special 01/26/2021SE
K201273ImageSPECTRUMNFJ · Traditional 09/25/2020SE
K201122Canon non-mydriatic retinal camera CR seriesHKI · Special 07/23/2020SE
K200887AS-10OWB · Special 04/15/2020SE
K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessMQB · Special 11/07/2019SE
K182942Canon OCT-A1OBO · Traditional 07/24/2019SE
K190368Enhanced Feature Software Pack CXDI SeriesMQB · Special 03/13/2019SE
K171270Digital Radiography CXDI-410C WirelessMQB · Traditional 11/17/2017SE
K171194AS-10, CXDI-401RFOWB · Traditional 05/24/2017SE
K170332Digital Radiography CXDI-710C Wireless, Digital Radiography CXDI-810C WirelessMQB · Traditional 03/01/2017SE
K153312Scatter Correction for Cxdi SeriesMQB · Traditional 06/28/2016SE
K143718Mammography Color Display DP-M3010PGY · Traditional 01/22/2015SE
K133693Digital Radiography CXDI-401C WirelessMQB · Traditional 07/01/2014SE
K131106Digital Radiography CXDI-701C Wireless, Digital Radiography CXDI-70IG Wireless, Digital…MQB · Traditional 07/03/2013SE
K111612Digital Retinal CameraHKI · Special 09/14/2011SE
K091545Digital Radiography CXDI-60CMQB · Traditional 06/15/2009SE
K091436Digital Radiography, Model CXDI-55CMQB · Traditional 05/29/2009SE
K091435Digital Radiography Model CXDI-55GMQB · Traditional 05/29/2009SE
K090466Digital Retinal Camera, CR-1 Mark IIHKI · Traditional 03/23/2009SE
K081648Digital Radiography CXDI-60GMQB · Traditional 06/24/2008SE
K080883CR-1HKI · Traditional 04/24/2008SE
K063717CF-1HKI · Traditional 01/23/2007SE
K062221CXDI-40ECMQB · Traditional 08/17/2006SE
K060433Digital Radiography CXDI-50CMQB · Traditional 03/10/2006SE
K050987Digital Radiography Model CXDI-40EGMQB · Traditional 04/27/2005SE
K041546Digital Fundus Camera, Model CF-60DSIHKI · Traditional 06/23/2004SE
K031447Canon, Digital Radiography, Model CXDI-50GMQB · Traditional 05/21/2003SE
K023124Canon X-Ray Digital Camera with Additional Software, Lanmix MLTMQB · Special 10/04/2002SE
K943939Non-Contact Tonometer T-2HKX · Traditional 05/12/1995SE
K940516Auto REFF-30HKO · Traditional 07/12/1994SE

Recalls

RecallProductInitiated
Z-1404-2013 Class IICanon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This…Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that… 12/05/2012Terminated
Z-2265-2012 Class IICanon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models…Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. 11/01/2010Terminated