FDA 510(k)

General Radiography CXDI-CS01

K-Number: K203849 · 2021-01-26

Decision Date2021-01-26

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

General Radiography CXDI-CS01 is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2021-01-26 under approval number K203849. 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 General Radiography CXDI-CS01?

General Radiography CXDI-CS01 is a medical device that received FDA 510(k) clearance on 2021-01-26. It is manufactured by Canon, Inc.. The 510(k) number is K203849.

When was General Radiography CXDI-CS01 approved by the FDA?

General Radiography CXDI-CS01 received FDA 510(k) clearance on 2021-01-26, under approval number K203849.

What company makes General Radiography CXDI-CS01?

General Radiography CXDI-CS01 is manufactured by Canon, Inc..

What is the FDA product code for General Radiography CXDI-CS01?

The FDA product code for General Radiography CXDI-CS01 is MQB.

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Official Source

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