Canon Inc.
FDA Regulatory Profile
Canon Inc. appears in FDA public data with 2 recalls, 43 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1404-2013, Class II) was initiated on December 5, 2012. Its most recent 510(k) clearance was granted on April 30, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 43
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1404-2013 | Class II | Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is | December 5, 2012 |
| Z-2265-2012 | Class II | Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CX | November 1, 2010 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252503 | Intelligent NR | April 30, 2026 |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | May 15, 2024 |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | April 26, 2024 |
| K230175 | Digital Radiography CXDI-CS01 | February 15, 2023 |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | October 17, 2022 |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | September 29, 2022 |
| K222661 | Digital Radiography CXDI-CS01 | September 27, 2022 |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | July 15, 2022 |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | June 14, 2022 |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | February 4, 2022 |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | January 24, 2022 |
| K212269 | Intelligent NR | September 17, 2021 |
| K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | September 9, 2021 |
| K203849 | General Radiography CXDI-CS01 | January 26, 2021 |
| K201273 | ImageSPECTRUM | September 25, 2020 |
| K201122 | Canon non-mydriatic retinal camera CR series | July 23, 2020 |
| K200887 | AS-10 | April 15, 2020 |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | November 7, 2019 |
| K182942 | Canon OCT-A1 | July 24, 2019 |
| K190368 | Enhanced Feature Software Pack CXDI Series | March 13, 2019 |