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FDA 510(k)

Digital Radiography CXDI-CS01

K-Number: K230175 · 2023-02-15

ApplicantCanon, Inc.
Decision Date2023-02-15
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Digital Radiography CXDI-CS01 is the device name listed in this FDA 510(k) record. The listed applicant is Canon, Inc.. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K230175. 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-CS01?

Digital Radiography CXDI-CS01 is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Canon, Inc.. The 510(k) number is K230175.

When did Digital Radiography CXDI-CS01 receive FDA 510(k) clearance?

Digital Radiography CXDI-CS01 received FDA 510(k) clearance on 2023-02-15, under 510(k) number K230175.

Who is the listed applicant for Digital Radiography CXDI-CS01?

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-CS01?

The FDA product code for Digital Radiography CXDI-CS01 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 BlK222855Digital Radiography CXDI-Pro, Digital Radiography D1K222687Digital Radiography CXDI-Elite, Digital Radiography E1K222661Digital Radiography CXDI-CS01

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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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