(15 days)
No
The summary describes a digital radiography detector that captures and converts X-ray images. There is no mention of AI, ML, or advanced image processing beyond basic digital conversion and display. The comparison to a predicate device also focuses on safety and effectiveness as a digital capture system, not on analytical or interpretive capabilities.
No
The device is used for digital image capture in diagnostic procedures, which is for identifying diseases, not for treating them.
Yes
The device's "Intended Use / Indications for Use" states that it is intended to "replace radiographic film/screen systems in all general purpose diagnostic procedures," indicating its role in diagnosis.
No
The device description explicitly states it is "designed for easy installation in bucky unit" and "used to directly capture and convert conventional projection X-ray images to digital images," indicating it is a hardware device that performs image capture and conversion, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides digital image capture for conventional film/screen radiographic examinations and is intended to replace those systems. This is a diagnostic imaging device, not a device used to examine specimens (like blood, urine, or tissue) outside the body.
- Device Description: The description reinforces that it captures and converts X-ray images, which are images of the inside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other typical components of an IVD.
IVDs are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is used to create images of the human body directly.
N/A
Intended Use / Indications for Use
DIGITAL RADIOGRAPHY CXDI-40G COMPACT 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
MQB
Device Description
DIGITAL RADIOGRAPHY CXDI-40G COMPACT, designed for easy installation in bucky unit, 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.
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)
The Performance Data demonstrate that CXDI-40G COMPACT is as safe and effective as CXDI-40EG.
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
KC9062-3
Section 10: Summary
510(k) Summary
Prepared:
.
January 7. 2009
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 Driscol |
|---|---|
| Phone Number: | (516) 328-5602 |
| Fax Number: | (516) 328-5169 |
Proposed Device:
Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
New Model Canon Inc. Canon CXDI-40G COMPACT MQB, Solid State X-ray Imager To be assigned
· Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon Inc. Canon CXDI-40EG 90MQB, Solid State X-rav Imager K050987
Description Of Device: DIGITAL RADIOGRAPHY CXDI-40G COMPACT, designed for easy installation in bucky unit, 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.
Intended Use: DIGITAL RADIOGRAPHY CXDI-40G COMPACT 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. T This device is not intended for mammography applications.
Comparison to Predicate: CXDI-40G COMPACT's intended use is the same as that of CXDI-40EG. However, the differences in design are as follows:
The External dimensions of CXDI-40G COMPACT are changed from 550x550x68mm to 543x470x32. Therefore, CXDI-40G COMPACT employs housing for easy installation in bucky unit.
Conclusion: The Performance Data demonstrate that CXDI-40G COMPACT is as safe and effective as CXDI-40EG. Based on the information in this submission, similarity to the predicate device (Digital Radiography CXDI-40EG), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXDL-40G COMPACT described in this submission is substantially equivalent to the predicate device
MAR 2 4 2009
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract representation of a human form or a symbol related to health and human services.
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. Jeff D. Rongero Third Party Reviewer, Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709
AUG 23 2013
Re: K090623
Trade/Device Name: CXDI-40G COMPACT Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 6, 2009 Received: March 9, 2009
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of March 24, 2009.
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 for assessment in the encreating of 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 r va may, deretore, mance 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 11 your dovice to classino 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
2
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 requirements as bet for an are quarte as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication. - The FD 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 11 you desire openie and records your in Viro 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
3
Indications Statement
510(K)Number(if known):
Device Name: CXDI-40G COMPACT
Indications for Use:
DIGITAL RADIOGRAPHY CXD1-40G COMPACT provides digital image capture for conventional film/screen radiographic examinations.
Kogo623
The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
This device is not intended for mammography applications.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Ovar-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)
..
Sogni M. Wham
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
l of Page 1