FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Digital Radiography CXDI-Pro, Digital Radiography D1
K Number: K221876
·
Decision Jul 15, 2022
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
43
Review Days
17
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Basic Information
- Device Name
- Digital Radiography CXDI-Pro, Digital Radiography D1
- K Number
- K221876
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon, Inc.
- Date Received
- June 28, 2022
- Decision Date
- July 15, 2022
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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|---|---|---|---|
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| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Apr 26, 2024 | Substantially Equivalent |
| K230175 | Digital Radiography CXDI-CS01 | Feb 15, 2023 | Substantially Equivalent |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Oct 17, 2022 | Substantially Equivalent |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Sep 29, 2022 | Substantially Equivalent |
| K222661 | Digital Radiography CXDI-CS01 | Sep 27, 2022 | Substantially Equivalent |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Jun 14, 2022 | Substantially Equivalent |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Feb 4, 2022 | Substantially Equivalent |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | Jan 24, 2022 | Substantially Equivalent |