(79 days)
Not Found
No
The summary describes a standard digital radiography detector and image capture system without mentioning any AI/ML capabilities or image processing beyond basic signal conversion and display.
No
The device is described as an x-ray imager for diagnostic procedures, which captures images but does not actively treat or modify bodily functions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device description clearly states it is a "solid state x-ray imager" and describes physical components like a scintillator, photo-detectors, and housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device is a "solid state x-ray imager" used for "digital image capture for conventional film/screen radiographic examinations." It intercepts x-ray photons and produces digital images for display.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from a patient. Its function is solely related to capturing and processing radiographic images.
Therefore, the Digital Radiography CXDI-501G and CXDI-501C fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Digital Radiography CXD1-501G and CXD1-501C provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Product codes
90MQB, 90MOB
Device Description
The Digital Radiography CXDI-501G and CXDL-501C are solid state x-ray imagers which have 35.0 x 42.6 cm imaging area. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated it is converted to digital value. and the images will be displayed on monitors.
The CXDI-501G uses GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-501C uses Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. Both models employ housing for easy installation in stand and table unit.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K111682
Page 1 of 2
Section 5: 510(k) Summary
510(k) Summary
SEP - 2 2011
Prepared:
June 14, 2011
Submitter/Holder:
Company Name: Company Address:
Contact Person: Phone Number: Fax Number:
CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku Tokyo 146-8501, Japan Naoyasu Asaka 81-3-3758-2111 81-3-5482-3960
Proposed Device:
Reason For 510(k): Trade Name: Model Name:
Classification Name: FDA 510(k) #:
New Model Canon Digital Radiography CXDI-501G Digital Radiography CXDI-501C 90MQB, Solid State X-ray Imager To be assigned
Predicate Device:
Trade Name: Canon
FDA 510(k) #/Model Name:
K 103591/ Digital Radiography CXDI-401G COMPACT/CXDI-401C COMPACT K091436/ Digital Radiography CXDI-55C K091435/ Digital Radiography CXDI-55G Classification Name: 90MOB, Solid State X-ray Imager
Description of Device:
The Digital Radiography CXDI-501G and CXDL-501C are solid state x-ray imagers which have 35.0 x 42.6 cm imaging area. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated it is converted to digital value. and the images will be displayed on monitors.
The CXDI-501G uses GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-501C uses Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. Both models employ housing for easy installation in stand and table unit.
Intended Use:
The Digital Radiography CXD1-501G and CXD1-501C provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
Comparison to Predicate:
The imaging principle and intended use of the Digital Radiography CXDI-501G and CXDI-501C are the same as those of the predicate devices (Digital Radiography CXDI-401G COMPACT, CXDI-401C COMPACT, CXDI-55C or CXDI-55G).
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K 111\1682
Page 2 of 2
Section 5: 510(k) Summary
Performance testing:
The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.
Conclusion:
The Performance Data demonstrate that CXDI-501G and CXDI-501C are as safe and effective as the predicate devices (Digital Radiography CXD1-401G COMPACT, CXDI-401C COMPACT, CXDI-55C or CXDI-55G). Based on the information in this submission, similarity to the predicate devices, and the results of our design control activities and non-clinical testing, it is our opinion that the Digital Radiography CXDI-501G and CXDI-501C described in this submission are substantially equivalent to the oredicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol with three figures and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" to the right of the symbol. The symbol and text are in blue.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Naoyasu Asaka Staff manager Canon Inc. 30-2 Shimomaruko 3-Chrome OHTA-KU TOKYO 146-8501 JAPAN
AUG 2 3 2013
Re: K111682
Trade/Device Name: Canon/Digital Radiology, CXDI-501G/CXDI-501C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: June 27, 2011 Received: June 28, 2011
Dear Mr. Asaka:
This letter corrects our substantially equivalent letter of September 2, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
3
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in the quality of the seescribed in your Section 510(k) premarket will anow you to begin marketing your avrile as valence of your device to a legally marketed noutication. The IDA imanig of succion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice for your device of the engles Eyaluation and Safety at (301) 796-607), prease vonaot the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (27 CFFF at 065), processor of default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tour may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CXDI-501G and CXDI-501C
Indications for Use:
DIGITAL RADIOGRAPHY CXDI-501G and CXDI-501C provide digital image capture for conventional film/screen radiographic examinations.
These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
These devices are not intended for mammography applications.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Page ー of 1
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