(15 days)
Not Found
No
The summary describes a standard digital radiography imager and does not mention any AI or ML capabilities, image processing algorithms, or training/test data sets typically associated with AI/ML devices.
No
The device is described as an x-ray imager for diagnostic procedures, not a device that provides therapy or treatment.
Yes
The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures, explicitly stating its role in diagnostic imaging.
No
The device description explicitly states it is a "solid state x-ray imager" with a physical imaging area, indicating it is a hardware device that captures X-ray photons and converts them to electrical signals.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The DIGITAL RADIOGRAPHY CXDI-55C is an X-ray imager. It captures digital images of the inside of the body using X-rays. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "digital image capture for conventional film/screen radiographic examinations" and "to replace radiographic film/screen systems in all general purpose diagnostic procedures." This describes an imaging device, not a device for analyzing biological samples.
Therefore, based on the provided information, the DIGITAL RADIOGRAPHY CXDI-55C is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DIGITAL RADIOGRAPHY CXDI-55C 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, MOB
Device Description
The DIGITAL RADIOGRAPHY CXDI-55C is a solid state x-ray imager which has 35 x 43 cm imaging area. The DIGITAL RADIOGRAPHY CXDI-55C intercepts x-ray photons and the scintillator of the CXDI-55C emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the images are converted to digital and displayed on a monitor.
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 demonstrates that CXDI-55C is safe and effective just as the CXDI-50C.
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
KC91436
Section 10: Summary
MAY 2 9 2009
510(k) Summary
April 6, 2009
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 (216) 328-2169
Proposed Device:
Reason for 510(k): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
New Model Canon Inc. Canon CXDI-55C 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-50C 90MQB, Solid State X-ray Imager K060433
Description of Device:
The DIGITAL RADIOGRAPHY CXDI-55C is a solid state x-ray imager which has 35 x 43 cm imaging area.
The DIGITAL RADIOGRAPHY CXDI-55C intercepts x-ray photons and the scintillator of the CXDI-55C emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the images are converted to digital and displayed on a monitor.
Intended Use:
The DIGITAL RADIOGRAPHY CXDI-55C 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.
1
Section 10: Summary
Comparison to Predicate:
CXDI-55C's intended use is the same as that of CXDI-50C. The differences are the external dimensions and the weight which are:
The external dimensions of CXDI-55C are changed from 491 x 477 x 23 mm to 480 x 481 x 15 mm.
The weight of CXDI-55C is changed from 4.8kg to 3.4kg.
Conclusion:
The Performance Data demonstrates that CXDI-55C is safe and effective just as the CXDI-50C.
Based on the information in this submission, similarity to the predicate device (Digital Radiography CXDI-50C), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXDI-55C described in this submission is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized graphic of human figures in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the graphic.
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. Jeff D. Rongero Third Party Reviewer-Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
AUG 2 3 2013
Re: K091436 Trade/Device Name: CXDI-55C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 13, 2009 Received: May 14. 2009
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of May 29, 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 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
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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
Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications Statement
| 510(K)Number(if known): | K091436 |
|---|---|
| ------------------------- | --------- |
Device Name: CXDI-55C
· Indications for Use:
DIGITAL RADIOQRAPHY CXDI-55C provides digital image capture for
conventional film/screan radiographic examinations.
The device is intended to replace radiographio film/screen systems in all general purpose diagnostic procedures. "
This device is not intended for mammography applications.
Presoription Uso OR (Part 21 OFR 801 Subpert D)
Over-The-Counter Use (Part 21 OFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LIKE-CONTINUE ON ANOTHERT PAGE IF NEEDED).
Ooncurrence of CDRH, Office of Device Evaluation(ODE)
:
.
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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