Digital Radiography CXDI-401C Wireless
FDA 510(k) K133693 · Canon, Inc.
510(k) numberK133693
Submission
- Device name
- Digital Radiography CXDI-401C Wireless
- Applicant
- Canon, Inc.
Richardson, TX, US - Received
- December 3, 2013
- Decision date
- July 1, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K252503 | Intelligent NROWB · Traditional | 04/30/2026SE |
| K241049 | CANON Fundus Camera CR-10 (CR-10)HKI · Special | 05/15/2024SE |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless BlOWB · Traditional | 04/26/2024SE |
| K230175 | Digital Radiography CXDI-CS01MQB · Special | 02/15/2023SE |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | 10/17/2022SE |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special | 09/29/2022SE |
| K222661 | Digital Radiography CXDI-CS01MQB · Special | 09/27/2022SE |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | 07/15/2022SE |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special | 06/14/2022SE |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | 02/04/2022SE |
Questions and answers
When was Digital Radiography CXDI-401C Wireless cleared by the FDA?
Digital Radiography CXDI-401C Wireless (K133693) received a 510(k) decision of Substantially Equivalent on July 1, 2014, 210 days after the submission was received.
What is the product code of K133693?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.