Digital Radiography CXDI-CS01
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Canon Inc.
Identity
- Trade Name
- DIGITAL RADIOGRAPHY CXDI-CS01 EUDAMED
- Device Name
- CXDI-Pro EUDAMED
- Model / Reference
- Digital Radiography EUDAMEDBT8-1851 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04549292192896 EUDAMED
- Basic UDI-DI
- 4549292dr01CU EUDAMED
- 510(k) Number
- K230175 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Digital Radiography CXDI-CS01 is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for capturing high-resolution radiographic images of human anatomy. It functions as a digital replacement for traditional film/screen systems, enabling immediate image display and storage without the need for chemical processing. This device is classified as a Class II medical device under FDA regulations and is intended for general-purpose diagnostic radiography procedures.
The CXDI-CS01 is supplied as part of a radiography system and must comply with IEC 60601-1 for safety and performance. It is intended for single-use or reusable applications in clinical settings, depending on manufacturer guidelines, and is not inherently MRI-safe. The system includes associated components such as X-ray generators and image-capture computers, which must adhere to additional safety standards like IEC 62368-1 and CISPR 32/35. Authorised under FDA 510(k) clearance and MDR, this device is regulated for use in radiology environments.
Frequently asked questions
What is the primary purpose of the Digital Radiography CXDI-CS01 in a clinical setting?
The Digital Radiography CXDI-CS01 is designed as a Solid State X-Ray Imager (Flat Panel/Digital Imager) to replace traditional film/screen systems in radiography. It captures high-resolution images of human anatomy for general-purpose diagnostic radiography, enabling immediate digital display and storage—eliminating the need for chemical processing. This makes it ideal for routine X-ray procedures across radiology departments.
How is the CXDI-CS01 intended to be used in terms of single-use versus reusable applications?
The CXDI-CS01 is flexible in usage, as it can be employed for either single-use or reusable applications depending on the facility’s infection control protocols and manufacturer guidelines. While the device itself isn’t inherently single-use, its design allows for reprocessing if properly cleaned and maintained, aligning with clinical best practices for reusable medical devices.
What safety standards must the CXDI-CS01 and its associated components comply with?
The CXDI-CS01 itself must comply with IEC 60601-1 for safety and performance. Its associated components—such as X-ray generators and image-capture computers—must adhere to additional standards like IEC 62368-1 (electrical safety) and CISPR 32/35 (electromagnetic compatibility). These ensure the entire system operates safely in clinical environments.
What regulatory pathways has the CXDI-CS01 followed for market authorization?
The CXDI-CS01 has been authorized through FDA 510(k) clearance and the EU Medical Device Regulation (MDR). It is classified as a Class II medical device under FDA regulations, with a substantially equivalent (SESE) determination by the Radiology (RA) Advisory Committee. This means it meets FDA’s requirements for safety and effectiveness compared to predicate devices.
Is the CXDI-CS01 compatible with MRI environments, and if not, why?
No, the CXDI-CS01 is not inherently MRI-safe. Since it is an X-ray imaging device, it contains materials and components that could pose risks in an MRI environment, such as metallic parts or electronic systems that may interfere with magnetic fields or become hazardous. Always verify compatibility with MRI systems before use in mixed environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CXDI-CS01 - Canon Global, PDF CXDI-CS01 - Canon Global, Digital Radiography CXDI-CS01 (K222661) — FDA 510 (k) | Innolitics, CXDI Digital Radiography Systems | Canon Medical Systems USA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230175 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- FDA Applicant
- Canon, Inc.
Sources (2)
- FDA 510(k) K230175 24 fields · synced Sep 18, 2026
- EUDAMED 320afe57-81a1-4813-aaec-b18e61a6f009 61 fields · synced Jul 16, 2026