(12 days)
DIGITAL RADIOGRAPHY CXDI-60G 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.
The Canon digital radiography CXDI-60G is a solid state xrray imagers. The CXDI-60G intercepts x-ray photons and the scintillator of the CXDI-60G emits visible spectrum photons that illuminate an array of photodetectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value. The resultant output signal can be transmitted to remote viewing site. The Canon digital radiography CXDI-60C is different from CXDI-50G in the following respect - The imaging area of CXDI.60G is changed from 35x43cm to 23x28cm. The principle of the CXDI-60G is the same as the CXDI-50G, with some modifications of its housing in size and shape. The sensor of the CXDI-60G has the same characteristics as the CXDI-50G. The CXDI-60G 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-60G achieves performance stated herein(such as image capturing, DICOM transfer and etc.).
The provided text describes Canon's CXDI-60G digital radiography device, which is a solid-state X-ray imager. The 510(k) summary focuses on demonstrating substantial equivalence to its predicate device, the CXDI-50G (K031447).
Based on the provided text, the 510(k) submission primarily focuses on the technical specification changes and equivalence to an existing product, rather than a clinical study with detailed acceptance criteria and performance metrics for a new clinical application. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the substantial equivalence hinges on the CXDI-60G having the "same characteristics as the CXDI-50G" for its sensor, and its "imaging principle and intended use are the same." The key change is the imaging area size.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Imaging Principle | Same as CXDI-50G |
| Sensor Characteristics | Same as CXDI-50G |
| Intended Use | Same as CXDI-50G |
| Image Capturing Performance | Achieved when paired with a general-purpose computer and designated system software (no specific metrics provided) |
| DICOM Transfer Performance | Achieved when paired with a general-purpose computer and designated system software (no specific metrics provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical test set for performance evaluation. The submission relies on technical comparisons to its predicate device. Therefore, information on sample size, country of origin, or retrospective/prospective nature of data is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Since no clinical test set is described, there is no information about experts or ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned or described. The submission focuses on device equivalence, not clinical effectiveness studies with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device described is a digital X-ray imager, a hardware component. Its performance relies on the image capture and processing capabilities that are inherent in the device and the associated software. While it operates "standalone" in the sense of capturing an image without human intervention at the moment of capture, the document doesn't provide performance metrics as a standalone algorithm for diagnostic interpretation. The focus is on the hardware's ability to produce images comparable to the predicate.
7. The Type of Ground Truth Used:
No clinical ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for comparison or validation in the provided text. The "ground truth" for this 510(k) is essentially the performance and characteristics of the legally marketed predicate device, the CXDI-50G.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable to this type of 510(k) submission which focuses on hardware equivalence rather than an AI/algorithmic model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned in the context of this device.
{0}------------------------------------------------
Section 10: Summary
JUN 2 4 2008
510(k) Summary
Prepared:
April 30, 2008
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): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
New Model Canon Inc. Canon CXDI-60G 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-50G 90MQB, Solid State X-ray Imager K031447
Description Of Device: The Canon digital radiography CXDI-60G is a solid state xrray imagers. The CXDI-60G intercepts x-ray photons and the scintillator of the CXDI-60G emits visible spectrum photons that illuminate an array of photodetectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value.
The resultant output signal can be transmitted to remote viewing site
The Canon digital radiography CXDI-60C is different from CXDI-50G in the following respect
- The imaging area of CXDI.60G is changed from 35x43cm to 23x28cm.
The principle of the CXDI-60G is the same as the CXDI-50G, with some modifications of its housing in size and shape. The sensor of the CXDI-60G has the same characteristics as the CXDI-50G
The CXDI-60G 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-60G achieves performance stated herein(such as image capturing, DICOM transfer and etc.)
{1}------------------------------------------------
Section 10: Summarv
DIGITAL RADIOGRAPHY CXDI•60G provides digital image capture for Intended Use: 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 is Digital Radiography CXDI-50G cleared under Document Number K031447 on May 21.
The CXDI60C's amorphous silicon array specifications (including image size, pixel pitch, number of pixels), imaging principle and intended use are the same as those of CXDI-50G. However, the differences in the design are as follows:
● The imaging area of CXDI-60G is changed from 35x43cm to 23x28cm.
A removable, fixed grid is used for all of the CXDI-60G and the CXDI-50G. Those grids are instated inside the sensor housing and used for eliminating the scatter X-ray in exposures that use films.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, sans-serif font. To the left of the text is a symbol that is part of the department's logo.
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 Senior Project Manager Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709
AUG 2 3 2013
Re: K081648
Trade/Device Name: CXDI-60G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: June 10, 2008 Received: June 12, 2008
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of June 24, 2008.
We have reviewed your Section 510(k) premarket notification of intent to maket the indication indication indication indication indication indication indication indication ind we nave reviewed your becaon 910(t) presidentially equivalent (for the indications felerenced above and nave uctemined the actoredicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Americans, or to commerce pro- 1970, the chaoninen with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (Act) that to hot required to the general controls provisions of the Act. The 1 ou may, deretore, market me act include requirements for annual registration, listing of general condois provided of wactice, 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 If your device is classified (see as 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 Flease be advised that I DA 3 issumed on a bucce complies with other requirements of the Act that I DA has made a colorimiation administered by other Federal agencies. You must of any rederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, art.uang, or medical device reporting (reporting of
{3}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing pactice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter requirences as bet for in and quality of evice as described in your Section 510(k) premarket witi anow you to ogin 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 CFF Pars 801 and 11 you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Those 1200, process 2019.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (27 Of NY at 000), proma Problem/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 Tou may obtain other general merchanel 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 Statement
5.10(K)Number(if known): .
Device Name: CXDI-60G
Indications for Use:
DIGITAL RADIOGRAPHY CXDI-60G 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.
Prescription Use (Part 21 CFR 801 Subpart D) ાર
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)
Heilert
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081648
Page 1 of 1
§ 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.