(15 days)
No
The summary describes a digital radiography system for image capture and transmission, with no mention of AI or ML features for image analysis, processing, or interpretation.
No
The device is described as a diagnostic tool for capturing and converting X-ray images, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" states that the device "is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures."
No
The device description explicitly states it is used to "directly capture and convert conventional projection Xray images to digital images," indicating it includes hardware components for image acquisition (likely a detector panel).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that this device is for capturing and converting X-ray images of the human body, not analyzing biological samples.
- The device is used for "digital image capture for conventional film/screen radiographic examinations." This is a form of medical imaging, not in vitro diagnostics.
The information provided describes a digital radiography system, which is a type of medical imaging device used for diagnostic purposes, but it operates on the patient directly using X-rays, not on samples taken from the patient.
N/A
Intended Use / Indications for Use
DIGITAL RADIOGRAPHY CXDI-40EC 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. This device is not intended for mammography applications.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional projection Xray images to digital images. ರ್ಗ 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-40EC is different from CXDI-40EG and CXDI-40C in the following respect:
- Both the CXDI-40EC and the CXDI-40EG use the same amorphous silicon alley as the sensing means, however, the CXDI-40EC uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDI-40EG. The CXDI.40EC uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy Sulfide). Because of CsI which provides high x ray absorption as fluorescent screen, CXDI-40EC delivers diagnostic images with approximately half the x ray dosage required by CXDI-40EG and CXDI-40EC's DQE approximately doubles compared to CXDI-40EG.
The principle of the CXDI-40EC is the same as the CXDI-40C. The sensor of the CXDI-40EC has the same characteristics as the CXDI-40C. The CXDI-40EC 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-40EG achieves performance stated herein(such as image capturing. DICOM transfer and etc.)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Section 10: Summary
06222/
510(k) Summary
Prepared:
February 2006
AUG 1 7 2006
Submitter:
Company Name: Canon USA, Inc. (U.S. agent for Canon Inc.) Company Address: One Canon Plaza Lake Success, NY 11042 Contact Person: Ms. Sheila Driscoll Phone Number: (516) 328-5602
Fax Number: (516) 328-5169
Proposed Device:
| Reason For 510(k): | New Model |
|---|---|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | CXDI-40EC |
| Classification Name: | 90MQB, Solid State X-ray Images |
| FDA 510(k) #: | To be assigned |
Predicate Device:
| Manufacturer: | |
|---|---|
| Trade Name: | |
| Model Name: | |
| Classification Name: | |
| FDA 510(k) #: |
Canon Inc. Canon CXDI-40EG/CXDI-40C 90MQB, Solid State X-ray Imager K050987/ K031633
Description Of Device: The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional projection Xray images to digital images. ರ್ಗ 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-40EC is different from CXDI-40EG and CXDI-40C in the following respect:
-
- Both the CXDI-40EC and the CXDI-40EG use the same amorphous silicon alley as the sensing means, however, the CXDI-40EC uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDI-40EG. The CXDI.40EC uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy Sulfide). Because of CsI which provides high x ray absorption as fluorescent screen, CXDI-40EC delivers diagnostic images with approximately half the x ray dosage required by CXDI-40EG and CXDI-40EC's DQE approximately doubles compared to CXDI-40EG.
The principle of the CXDI-40EC is the same as the CXDI-40C. The sensor of the CXDI-40EC has the same characteristics as the CXDI-40C. The CXDI-40EC 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-40EG
- Both the CXDI-40EC and the CXDI-40EG use the same amorphous silicon alley as the sensing means, however, the CXDI-40EC uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDI-40EG. The CXDI.40EC uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy Sulfide). Because of CsI which provides high x ray absorption as fluorescent screen, CXDI-40EC delivers diagnostic images with approximately half the x ray dosage required by CXDI-40EG and CXDI-40EC's DQE approximately doubles compared to CXDI-40EG.
1
Section 10: Summary
achieves performance stated herein(such as image capturing. DICOM transfer and etc.)
Intended Use:
Canon digital radiography CXDI-40EC 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. This device is not intended for mammography applications.
Descriptive Comparison
The predicate devices are the Canon digital radiography CXDI.40EG cleared under Document Number K050987 on April 27, 2005 and CXDI-40C cleared under Document Number K031633 on June 11, 2003.
The CXDI.40EC's amorphous silicon array specifications (including image size, pixch, number of pixels), imaging principle and intended use are the same as those of CXDI.40EC and of CXDI-40C. However, the differences in the design are as follows:
- · Both the CXDI-40EC and the CXDI-40EG use the same amorphous silicon array as sensing means, however, the CXDI-40EC uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDI-40EG. The CXDI-40EC uses CsI (Cesium Iodide) while CXDI-40EG uses GOS (Gadolium Oxy Sulfide).
- · Because of Csl which provides high xray absorption as fluorescent screen. CXDI-40EC delivers diagnostic images with the x ray dosage less than that required by CXDI-40EG and CXDI-40EC's DQE approximately doubles compared to CXDI-40EG.
- · The CsI used in CXDI-40EC as fluorescent screen is equivalent to the material used in the other devices of the same intended use in the market.
- · Both the CXDI-40EC and the CXDI-40C use the same amorphous silicon array as sensing means and also uses the same material for fluorescent screen of CsI (Cesium Iodide) but are controlled with a different interface of PC.
- A removable, fixed grid is used for all of the CXDI-40EC, CXDI-40EG and the CXDI-40C. Those grids are instated inside the sensor housing and used for eliminating the scatter X ray in exposures that use films.
(See attached Table 4.2)
Regarding the software:
- The system software for controlling CXDI-40EC is released as V6.3. .
- V6.3 includes some changes from V6.0.
- · The main changes of the V6.3 are the addition of the control of CXDI-40EC sensor and some change of GUI.
- · V6.0 was first introduced and cleared under K031447 and is currently used in Canon models the CXDI-50G.
Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography CXDI.40EG and the CXDI.40C, and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI 40EC 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 logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure and the department's name in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Canon USA, Inc. % Mr. Jeffrey D. Rongero Senior Project Manager Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747
AUG 23 2013
Re: K062221 Trade/Device Name: CDXI-40EC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 27, 2006 Received: August 2, 2006
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of August 17, 2006.
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
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
Janine M. Mdrri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 3: Statement
Indications for Use
510(k) Number (if known):