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FDA 510(k)

DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1

K-Number: K213780 · 2022-01-24

ApplicantCanon, Inc.
Decision Date2022-01-24
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 2022-01-24 under approval number K213780. 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 2022-01-24. It is manufactured by Canon, Inc.. The 510(k) number is K213780.

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 2022-01-24, under approval number K213780.

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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