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FDA 510(k)

DIGITAL RADIOGRAPHY CXDI-Pro, D1

K-Number: K212553 · 2021-09-09

ApplicantCanon, Inc.
Decision Date2021-09-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL RADIOGRAPHY CXDI-Pro, D1 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K212553. 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-Pro, D1?

DIGITAL RADIOGRAPHY CXDI-Pro, D1 is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Canon, Inc.. The 510(k) number is K212553.

When did DIGITAL RADIOGRAPHY CXDI-Pro, D1 receive FDA 510(k) clearance?

DIGITAL RADIOGRAPHY CXDI-Pro, D1 received FDA 510(k) clearance on 2021-09-09, under 510(k) number K212553.

Who is the listed applicant for DIGITAL RADIOGRAPHY CXDI-Pro, D1?

The FDA 510(k) record lists Canon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL RADIOGRAPHY CXDI-Pro, D1?

The FDA product code for DIGITAL RADIOGRAPHY CXDI-Pro, D1 is MQB.

Other records listing Canon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252503Intelligent NRK241049CANON Fundus Camera CR-10 (CR-10)K232298DIGITAL RADIOGRAPHY CXDI-RF Wireless BlK230175Digital Radiography CXDI-CS01K222855Digital Radiography CXDI-Pro, Digital Radiography D1K222687Digital Radiography CXDI-Elite, Digital Radiography E1

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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