FDA Registration
Active
🇯🇵 Japan
Canon.Inc
Reg #: 3038614464
·
FEI: 3038614464
·
Expires 2026
Products
11
Proprietary Names
32
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Canon.Inc
- Registration Number
- 3038614464
- FEI Number
- 3038614464
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30-2, SHIMOMARUKO 3-CHOME,
- City
- OHTA-KU Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K170332
Owner / Operator
- Firm Name
- CANON INC.
- Operator Number
- 8030410
- Address
- 30-2 SHIMOMARUKO, 3-CHOME,
- City
- OHTA-KU
- State
- Tokyo
- Postal Code
- 146-8501
- Country
- JP
US Agent
- Business Name
- Canon Medical Components U.S.A., Inc.
- Contact Name
- John CORWIN
- Address
- 2355 Main St Ste 150
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
- [email protected]
- Phone
- 949 2412582
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2017-03-02 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2001-05-25 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2017-01-30 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2020-07-26 |
| System, Image Management, Ophthalmic | NFJ | Class 2 | Radiology | No | 2020-07-26 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2012-06-19 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2011-10-24 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2002-05-09 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2019-07-24 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2019-07-24 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2013-07-17 |
Proprietary Names
DIGITAL RADIOGRAPHY CXDI-710C Wireless, CXDI-810C Wireless
CANON DR IMAGE VIEWER
CXDI-401G, CXDI-401C, CXDI-401G COMPACT, CXDI-401C COMPACT
CSX-30 Flat Panel Detector
CXDI-70C Wireless
Digital Retinal Camera CR-2 Plus AF
Digital Retinal Camera CR-2 AF
CSX-20
CXDI-55G
Ophthalmic Software Platform RX
DIGITAL RADIOGRAPHY E1
DIGITAL RADIOGRAPHY CXDI-Elite
Full Auto Tonometer TX-20
CF-1
FULL AUTO REF-KERATOMETER RK-F2
AUTOREF LENSMETER RL-10
FULL AUTO REF-KERATOMETER RK-F3m
CANON AUTO REF-KERATOMETER RK-3
Optical Coherence Tomography OCT-A1
DIGITAL RADIOGRAPHY CXDI-702C Wireless, CXDI-402C Wireless
DYNAMIC/STATIC DR CXDI-50RF
DIGITAL RADIOGRAPHY CXDI-Pro
DIGITAL RADIOGRAPHY D1
DIGITAL RETINAL CAMERA CX-1
CXDI-55C
DIGITAL RADIOGRAPHY CXDI-401C Wireless
imageSPECTRUM
DIGITAL RADIOGRAPHY CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, CXDI-801G Wireless
Digital Retinal Camera CR-10
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
CXDI-501G, CXDI-501C
CXDI-40G COMPACT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility