Canon Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
42
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1404-2013Class IICanon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is December 5, 2012
Z-2265-2012Class IICanon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXNovember 1, 2010

Recent 510(k) Clearances

K-NumberDeviceDate
K241049CANON Fundus Camera CR-10 (CR-10)May 15, 2024
K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlApril 26, 2024
K230175Digital Radiography CXDI-CS01February 15, 2023
K222855Digital Radiography CXDI-Pro, Digital Radiography D1October 17, 2022
K222687Digital Radiography CXDI-Elite, Digital Radiography E1September 29, 2022
K222661Digital Radiography CXDI-CS01September 27, 2022
K221876Digital Radiography CXDI-Pro, Digital Radiography D1July 15, 2022
K221620Digital Radiography CXDI-Elite, Digital Radiography E1June 14, 2022
K220098Digital Radiography CXDI-Pro, Digital Radiography D1February 4, 2022
K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1January 24, 2022
K212269Intelligent NRSeptember 17, 2021
K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1September 9, 2021
K203849General Radiography CXDI-CS01January 26, 2021
K201273ImageSPECTRUMSeptember 25, 2020
K201122Canon non-mydriatic retinal camera CR seriesJuly 23, 2020
K200887AS-10April 15, 2020
K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C WirelessNovember 7, 2019
K182942Canon OCT-A1July 24, 2019
K190368Enhanced Feature Software Pack CXDI SeriesMarch 13, 2019
K171270DIGITAL RADIOGRAPHY CXDI-410C WIRELESSNovember 17, 2017