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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 the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2019-03-13 under 510(k) 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. The listed applicant is Canon, Inc.. The 510(k) number is K190368.

When did Enhanced Feature Software Pack CXDI Series receive FDA 510(k) clearance?

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

Who is the listed applicant for Enhanced Feature Software Pack CXDI Series?

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 Enhanced Feature Software Pack CXDI Series?

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

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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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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