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FDA 510(k)

Digital Radiography CXDI-Elite, Digital Radiography E1

K-Number: K221620 · 2022-06-14

ApplicantCanon, Inc.
Decision Date2022-06-14
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Radiography CXDI-Elite, Digital Radiography E1 is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2022-06-14 under approval number K221620. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Radiography CXDI-Elite, Digital Radiography E1?

Digital Radiography CXDI-Elite, Digital Radiography E1 is a medical device that received FDA 510(k) clearance on 2022-06-14. It is manufactured by Canon, Inc.. The 510(k) number is K221620.

When was Digital Radiography CXDI-Elite, Digital Radiography E1 approved by the FDA?

Digital Radiography CXDI-Elite, Digital Radiography E1 received FDA 510(k) clearance on 2022-06-14, under approval number K221620.

What company makes Digital Radiography CXDI-Elite, Digital Radiography E1?

Digital Radiography CXDI-Elite, Digital Radiography E1 is manufactured by Canon, Inc..

What is the FDA product code for Digital Radiography CXDI-Elite, Digital Radiography E1?

The FDA product code for Digital Radiography CXDI-Elite, Digital Radiography E1 is MQB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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