(8 days)
Not Found
No
The summary describes a digital radiography detector and its function of capturing and converting X-ray images. There is no mention of AI, ML, or any advanced image processing that would suggest the use of these technologies. The focus is on the hardware and basic digital image handling.
No
This device is an X-ray image capture system used for diagnostic imaging, not for providing therapy.
Yes
Explanation: The device is described as being used in "all general purpose diagnostic procedures" and its purpose is to "capture and convert conventional projection X-ray images to digital images," which are then used for diagnostic purposes. It also explicitly mentions transmitting the "diagnostic image."
No
The device description explicitly states it is a "component without a control PC" and is used to "directly capture and convert conventional projection X-ray images to digital images." This indicates the device includes hardware for image capture and conversion, not just software.
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 "DIGITAL RADIOGRAPHY" system used to capture and convert conventional projection X-ray images. This is an imaging modality that works externally to the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for "general purpose diagnostic procedures" using X-rays, which aligns with medical imaging, not in vitro testing.
Therefore, the Canon digital radiography CXDI-40EG falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
DIGITAL RADIOGRAPHY CXDI-40EG is used to directly capture and convert conventional projection X-ray images to digital images. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Product codes
MQB,MOB
Device Description
The Canon digital radiography CXDI-40EG is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
The Canon digital radiography CXDI-40EG is different from CXDI-40G in the following respect:
- The CXDI-40EG itself is a component without a control PC. Using a general . purpose computer with appropriate specifications and the designated system software installed in it, as a control PC, the CXDI-40G achieves performance stated herein (such as image capturing, DICOM transfer and etc.) predicate devices.
The CXDI-40EG can be characterized as almost an equivalent model to the CXDI-40G with a new software version and with a different interface of control PC. The sensor element of the The images taken with the CXDI-40EG has identical characteristics to the CXDI-40G. CXDI-40EG will be equivalent to the CXDI-40G.
Mentions image processing
Not Found
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)
Not Found
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
510(k) Summary
February 9, 2005
Prepared:
Submitter:
Company Name: Company Address:
Contact Person: Phone Number: Fax Number:
Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Ms. Sheila Driscoll (516) 328-5602 (516) 328-5169
Proposed Device:
Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: Regulation Number: FDA 510(k) #:
New Model Canon Inc. Canon CXDI-40EG *** MQB, Solid State X-ray Imager 892.1650 To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: Regulation Number: FDA 510(k) #:
Canon Inc. Canon CXDI-40G MQB, Solid State X·ray Imager 892.1650/892.1630 K023750
Description Of Device:
The Canon digital radiography CXDI-40EG is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
The Canon digital radiography CXDI-40EG is different from CXDI-40G in the following respect:
- The CXDI-40EG itself is a component without a control PC. Using a general . purpose computer with appropriate specifications and the designated system software installed in it, as a control PC, the CXDI-40G achieves performance stated herein (such as image capturing, DICOM transfer and etc.) predicate devices.
The CXDI-40EG can be characterized as almost an equivalent model to the CXDI-40G with a new software version and with a different interface of control PC. The sensor element of the The images taken with the CXDI-40EG has identical characteristics to the CXDI-40G. CXDI-40EG will be equivalent to the CXDI-40G.
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Section 10: Summary
Intended Use:
Digital radiography CXDI-40EG provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Descriptive Comparison:
The predicate devices are the digital radiography CXDI-40G cleared under Document Number K023750 on November 22, 2002.
The CXDI-40EG's technical specifications (including image size, pixel pitch, number of pixels), imaging principle, physical characteristics and intended use are the same as those of CXDI-40G.
Regarding the software:
- The system software for controlling CXDI-40EG is released as V6.3. .
- V6.3 includes some changes from V5.0. .
- The main changes of the V6.3 are the addition of the control of CXDI-40EG sensor and some ● change of GUI.
- V5.0 was first introduced and cleared under K023750 and is currently used in Canon . models CXDI-40EG. ﺪ ﻟ
Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40EG described in this submission is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Canon, Inc. % Mr. Williams J. Sammons Reviewer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709
AUG 23 2013
Re: K050987
Trade/Device Name: CXDI-40EG Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 18, 2005 Received: April 19, 2005
Dear Mr. Sammons:
This letter corrects our substantially equivalent letter of April 27, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regar. J annual date of the Medical Device Amendments, or to commerce phor to May 20, 1970, are oncordance 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 Tou may, dicierore, manel as act include requirements for annual registration, listing of general controls provisions of the fiel 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 11 your device is clusified (ove acor 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 1 Toast of advised that I Dri 3 1500mm on the complies with other requirements of the Act that I Dri has made a determinations administered by other Federal agencies. You must of any I cach statutes and regulations ancluding, but not limited to: registration and listing (21 Comply with an the rice of requirements, art.us 801 and 809); medical device reporting of
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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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Division 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
KoSo987 510(k) Number (if known):
Device Name: CXDI-40EG
Indications For Use:
DIGITAL RADIOGRAPHY CXDI-40EG is used to directly capture and convert conventional projection X-ray images to digital images. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadon
(Division Sian-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
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