Digital Radiography CXDI-710C Wireless, Digital Radiography CXDI-810C Wireless
FDA 510(k) K170332 · Canon, Inc.
510(k) numberK170332
Submission
- Device name
- Digital Radiography CXDI-710C Wireless, Digital Radiography CXDI-810C Wireless
- Applicant
- Canon, Inc.
Nakahara-Ku, Kawasaki, JP - Received
- February 2, 2017
- Decision date
- March 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1MQB · Special | 07/15/2022SE |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1MQB · Special | 06/14/2022SE |
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Questions and answers
When was Digital Radiography CXDI-710C Wireless, Digital Radiography CXDI-810C Wireless cleared by the FDA?
Digital Radiography CXDI-710C Wireless, Digital Radiography CXDI-810C Wireless (K170332) received a 510(k) decision of Substantially Equivalent on March 1, 2017, 27 days after the submission was received.
What is the product code of K170332?
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.