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FDA 510(k)

Enhanced Feature Software Pack CXDI Series

K-Number: K190368 · 2019-03-13

ApplicantCanon, Inc.
Decision Date2019-03-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Enhanced Feature Software Pack CXDI Series is a medical device manufactured by Canon, Inc.. It received FDA 510(k) clearance on 2019-03-13 under approval number K190368. 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 Enhanced Feature Software Pack CXDI Series?

Enhanced Feature Software Pack CXDI Series is a medical device that received FDA 510(k) clearance on 2019-03-13. It is manufactured by Canon, Inc.. The 510(k) number is K190368.

When was Enhanced Feature Software Pack CXDI Series approved by the FDA?

Enhanced Feature Software Pack CXDI Series received FDA 510(k) clearance on 2019-03-13, under approval number K190368.

What company makes Enhanced Feature Software Pack CXDI Series?

Enhanced Feature Software Pack CXDI Series is manufactured by Canon, Inc..

What is the FDA product code for Enhanced Feature Software Pack CXDI Series?

The FDA product code for Enhanced Feature Software Pack CXDI Series is MQB.

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Related PubMed Literature

PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

Other Devices by Canon, Inc.

K153312SCATTER CORRECTION FOR CXDI SERIES K171270DIGITAL RADIOGRAPHY CXDI-410C WIRELESS K171194AS-10, CXDI-401RF K170332DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless K182942Canon OCT-A1

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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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