FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
K Number: K213780
·
Decision Jan 24, 2022
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
43
Review Days
53
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Basic Information
- Device Name
- DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
- K Number
- K213780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon, Inc.
- Date Received
- December 2, 2021
- Decision Date
- January 24, 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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Other Clearances by Canon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252503 | Intelligent NR | Apr 30, 2026 | Substantially Equivalent |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | May 15, 2024 | Substantially Equivalent |
| 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 |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Jul 15, 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 |