(14 days)
Not Found
No
The summary describes a digital radiography system that replaces film/screen systems and performs basic digital image processing (gray-scale optimization). There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or other sections. The focus is on digital image capture and transmission.
No
The device is described as a digital radiography system intended for diagnostic imaging, not for treating any medical condition.
Yes
The device is described as supporting "general purpose diagnostic procedures" and providing "digital image capture for conventional film/screen radiographic examinations," which are inherently diagnostic in nature.
No
The device description explicitly states it is used to "directly capture and convert conventional projection X-ray images to digital images," indicating the presence of hardware components for image acquisition.
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 is for "digital image capture for conventional film/screen radiographic examinations" and is intended to "replace radiographic film/screen systems in all general purpose diagnostic procedures." This describes an imaging device used to capture images of the human body, not a device used to examine specimens taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces this by stating it "directly capture and convert conventional projection X-ray images to digital images." This is a description of an imaging process, not an in vitro diagnostic test.
- Input Imaging Modality: The input is "conventional projection X-ray," which is an imaging modality used on the patient, not on a sample.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Canon digital radiography CXDI-40G 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.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Canon digital radiography CXDI-40G 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-40G is different from CXDI-11 and CXDI-22 in the following respect:
· The CXDI-40G operates in conjunction with an upright stand, table, and universal stand while the CXDI-11 operates only in conjunction with an upright stand, and the CXDI-22 only operates in conjunction with a table.
Mentions image processing
After digital processing ( optimize the gray-scale)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
General radiography
Indicated Patient Age Range
General population
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.
Not Found
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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510(k) Summary
Prepared:
August 8, 2002
Submitter:
Company Name: Canon USA, Inc. (U.S. agent/official correspondent for Canon Inc.) Company Address: One Canon Plaza
Contact Person: Phone Number: Fax Number:
Lake Success, NY 11042 Ms. Sheila Driscoll (516) 328-5602 (216) 328-2169
Proposed Device:
| Reason For 510(k): | New Model |
|---|---|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | CXDI-40G |
| Classification Name: | MQB, Solid State X-ray Imager |
| FDA 510(k) #: | To be assigned |
Predicate Device:
| Manufacturer: | Canon Inc. |
|---|---|
| Trade Name: | Canon |
| Model Name: | CXDI-11/CXDI-22 |
| Classification Name: | 90MQB, Solid State X-ray Image- |
| FDA 510(k) #: | K981556/K992547 |
Description Of Device:
The Canon digital radiography CXDI-40G 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-40G is different from CXDI-11 and CXDI-22 in the following respect:
· The CXDI-40G operates in conjunction with an upright stand, table, and universal stand while the CXDI-11 operates only in conjunction with an upright stand, and the CXDI-22 only operates in conjunction with a table.
Intended Use:
Canon digital radiography CXDI-40G 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.
Technical Characteristics:
Please refer to the attached COMPARISON CHART.(Table 10)
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Descriptive Comparison
The predicate device is the Canon digital radiography CXDI-11 cleared under Document Number K981556 on November 4, 1998 and CXDI-22 cleared under Document Number K992547 on October 13, 1999.
The CXDI-40G'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-11 and CXDI-22. However, the differences in the design are as follows:
- · The mechanical structure and physical appearance of the CXDI-40G are different than the CXDI-11 and CXDI-22. Please refer to the attached CXDI-40G comparison table provided in this section. Additional information can also be found in the CXDI-40G Operation Manual provided in this submission.
- · The CXDI-40G can be used with upright stand, table, and universal stand by using the installation unit for each application, while the CXDI-11 is used with upright stand only and the CXDI-22 is only used with a table.
- · A removable, fixed grid is used for the CXDI-40G, while an implemented, moving grid is used for the CXDI-11 and a removable moving grid is used for the CXDI-22. Both types of grids are used for eliminating the dispersed X-ray in exposures that use films. (See attached Table 4.2)
Regarding the software:
- The system software for controlling CXDI-40G is released as V5.0. 8
- l V5.0 includes some changes from V4.1.
- · The main changes of the V5.0 are the addition of the control of CXDI-40G sensor and some change of GUI.
- · V4. I was first introduced and cleared under K003689 and is currently used in Canon models CXDI-11, CXDI-22, and CXDI-31.
- · The comparison between V5.0 and V4.1 is described in the Software Information for model CXDI-40G section.
Based on the information in this submission, similarity to the predicate devices (Canon digital radiography CXDI-11 and CXDI-22), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40G described in this submission is substantially equivalent to the predicate devices
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| comparison
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| 0
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| able |
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| Item | CXDI-11 | CXDI-22 | CXDI-40G | |
|---|---|---|---|---|
| FDA 510(k)# | K981556 | K992547 | Proposed Device | |
| Intended Use | Provide diagnostic images for general | Provide diagnostic images for general | Provide diagnostic images for general | |
| Design | radiography with upright system, | |||
| Digital acquisition, | ||||
| electronic processing | radiography with table system | radiography | ||
| Energy Uses | Receives x-radiation generated by external diagnostic x-ray generator | Same | Same | |
| X-ray Absorber | Fluorescent screen (Gd2O2S:TB3+) | Same | Same | |
| Materials | Visible emission peak: 545nm | |||
| Item | CXDI-11 | CXDI-22 | CXDI-40G | |
| Sensing | Amorphous Silicon W/TFT Array | Same | Amorphous Silicon W/TFT Array | |
| Detection peak: 540- 620nm | Same | Detection peak: 540- 620nm | ||
| Anatomical Sites | General radiography | Same | Same | |
| Target Population | General population | Same | Same | |
| Physical Safety | Minimize exposure to x-radiation | Same | Same | |
| Compliance with Standard | Complies with IEC 601-1-2 | Same | Same | |
| Biocompatibility | N/A | N/A | N/A | |
| Performance | After digital processing ( optimize the | Same | Same | |
| gray-scale) | Same | Same | ||
| Labeling | Approved 510(K) | Approved 510(K) | Approved 510(K) | |
| Pixel | 2688 × 2688 pixels | Same | Same | |
| Item | CXDI-11 | CXDI-22 | CXDI-40G | |
| (7,200,000 pixels) | Same | Same | ||
| Image size | 43cm x 43cm | Same | Same | |
| Pixel pitch | 160 μ m | Same | Same | |
| MTF | MTF@2lp/mm 42% | Same | Same | |
| Dynamic Range | Dynamic range: | |||
| approximately 4 digit | ||||
| ( linear A/D : 14bit) | ||||
| ( output data : 12bit) | Same | Same | ||
| Grid | Moving grid | Moving grid | ||
| ( removable ) | Stationary grid | |||
| ( removable ) | ||||
| Sensor Unit Dimension | 552 x 598 x 231mm | 604 x 645 x 73.50r69mm | 550x 550 x 68mm | |
| Item | CXDI-11 | CXDI-22 | CXDI-40G | |
| Power Supply Dimension | 580 x 489 x 275mm | 390 x 160 x 110mm | 390 x 160 x 110mm | |
| Control PC Dimension | 483.5 x 594 x 300mm | 453 x 594 x 300mm | 453 x 594 x 300mm | |
| Operation Unit Dimension | 298 x 209.5 x 130mm | Same | 398 x 395 x 150 | |
| Card Reader Dimension | 50 x 180 x 39mm | Same | Same | |
| Stand Dimension | 900 x 475 x 2100mm | N/A | (900 x 480 x 2000) * | |
| Table Dimension | N/A | (2025 x 820 x 890) * | (2025 x 820 x 890) * |
3
:
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4
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5
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*: These dimensions are anylicable for the stand and the table made by canon inc. It is possible to use another stands and tables.
6
Image /page/6/Picture/0 description: The image is a black and white 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 an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body.
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. % Ms. Pamela K. Gwynn Engineering Team Leader Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
AUG 23 2013
Re: K023750
Trade/Device Name: Canon Digital Radiography Model CXDI-40G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 7, 2002 Received: November 8, 2002
Dear Ms. Gwynn:
This letter corrects our substantially equivalent letter of November 22 2002.
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
7
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
8
Section 3: Statement
Indications Statement
Page l of I
510(K)Number(if known): KU23
Device Name:
Indications for Use:
CANON DIGITAL RADIOGRAPHY CXDI-40G 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
David h. Lippman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 3-1