(112 days)
DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXD1-401G CXD1-401C, CXD1-401G COMPACT and CXDI-401C COMPACT are solid state x-ray imagers which have 41.5 x 42.6cm imaging area. The device intercents x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The CXDI-401G and CXDI-401G COMPACT use GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-401C and CXDI-401C COMPACT use Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. The CXDI-401G COMPACT and CXDI-401C COMPACT employ housing for easy installation in stand unit and table unit.
The provided text describes a 510(k) Summary for the Canon DIGITAL RADIOGRAPHY CXDI-401G/C and COMPACT models. It outlines the device description, intended use, comparison to predicate devices, and performance testing. However, it does not contain specific information regarding device acceptance criteria, reported performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or training set details.
The document focuses on demonstrating substantial equivalence to predicate devices through electrical safety, electromagnetic compatibility, and other performance tests, but it does not provide the detailed study information requested.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The implicit acceptance criteria are that the device is "safe and effective" and "equivalent to the predicate devices" based on general performance testing.
- Reported Device Performance:
- "The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices."
- No specific quantitative performance metrics (e.g., image quality scores, diagnostic accuracy) are reported for the new devices or compared against predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document only mentions "other performance testings" without detailing the nature of these tests or the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/not specified. The testing described appears to be technical performance testing (electrical safety, EMC) rather than diagnostic efficacy testing involving expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified, as diagnostic efficacy testing is not described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The device described is a digital radiography imager, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. The device is hardware (an imager), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not specified, as diagnostic efficacy testing is not described. For electrical safety and EMC, ground truth would be established by relevant engineering standards.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device, not a machine learning algorithm.
{0}------------------------------------------------
Section 5: 510(k) Summary
K103591
510(k) Summary
MAR 2 9 2011
Prepared:
December 3, 2010
Tokyo 146-8501, Japan
30-2 Shimomaruko 3-chome, Ohta-ku
DIGITAL RADIOGRAPHY CXDI-401G DIGITAL RADIOGRAPHY CXDI-401C
Canon Inc.
Naoyasu Asaka
81-3-3758-2111
81-3-5482-3960
New Model
Canon Inc.
Submitter/Holder: Company Name:
Company Address:
Contact Person: Phone Number: Fax Number:
Proposed Device:
Reason For 510(k): Trade Name: Model Name:
Classification Name: FDA 510(k) #:
Predicate Device:
Trade Name: FDA 510(k) #/Model Name:
DIGITAL RADIOGRAPHY CXDI-401G COMPACT DIGITAL RADIOGRAPHY CXDI-401C COMPACT 90MQB, Solid State X-ray Imager To be assigned
Classification Name:
: K102012
Canon Inc.
K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless K090623/ DIGITAL RADIOGRAPHY CXDI-40G COMPACT K062221/DIGITAL RADIOGRAPHY CXDI-40EC K050987/ DIGITAL RADIOGRAPHY CXD1-40EG 90MQB, Solid State X-ray Imager
Description of Device:
The DIGITAL RADIOGRAPHY CXD1-401G CXD1-401C, CXD1-401G COMPACT and CXDI-401C COMPACT are solid state x-ray imagers which have 41.5 x 42.6cm imaging area. The device intercents x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.
The CXDI-401G and CXDI-401G COMPACT use GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-401C and CXDI-401C COMPACT use Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen.
The CXDI-401G COMPACT and CXDI-401C COMPACT employ housing for easy installation in stand unit and table unit.
Intended Use:
RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and DIGITAL CXDJ-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations.
These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
These devices are not intended for mammography applications.
{1}------------------------------------------------
Section 5: 510(k) Summary
Comparison to Predicate:
The imaging principle and intended use of the DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT are the same as those of the predicate devices (CXD1-70C Wireless, CXD1-40G COMPACT, CXD1-40EC or CXD1-40EG).
Performance testing:
The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.
Conclusion:
The Performance Data demonstrate that CXD1-401 G, CXD1-401 G, CXD1-401 G COMPACT and CXDI-401C COMPACT are as safe and effective as the predicate devices (DIGITAL RADIOGRAPHY CXDI-70C Wireless, CXDI-40G COMPACT, CXDI-40EC or CXDI-40EG), Based on the information in this submission, similarity to the predicate devices, and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXDI-401G CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT described in this submission are substantially equivalent to the predicate devices.
{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, uppercase letters. To the left of the text is a symbol that is part of the department's official branding.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Canon, Inc. - Medical Equipment Group % Mr. Koji Kubo Manager Cosmos Corporation - Tokyo Office 3F 2-17-6 Akebono-cho TACHIKAWA-SHI TOKYO 190-0012 JAPAN
AUG 23 2013
Re: K103591
Trade/Device Name: CXDI-401G, CDXI-401C, CDXI-401G COMPACT and CDXI-401C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 25, 2011 Received: February 28, 2011
Dear Mr. Kubo:
This letter corrects our substantially equivalent letter of March 29, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars analysis possible perice Amendments, or to comments to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices ulat have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Ret) market the device, subject to the general controls provisions of the Act. The Tou may, dicierore, market the devices, obly over equirements for annual registration, listing of general controls provisions of the lice, 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 (600 acorre) in the major regulations affecting your device can be found in Title 21, additional controls. Distant major regates 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 I lease be advised that I Dr I s issualled or our device complies with other requirements of the Act that I DA has made a doterimation administered by other Federal agencies. You must of any I edelal statutes and regulations and limited to: registration and listing (21 Compy with an the fict 6 requirements, 801 and 809); medical device reporting (reporting of
{3}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse overse (OS) regulation (21 CFR Part 820). This letter requirements as set forth in the quality of cribed in your Section 510(k) premarket whil allow you to begin markemig your active as valence of your device to a legally marketed noutication. THC FDF Imaging of clestion 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) Parts 801 and II you desire specific advice for your do novel cases graluation and Safety at (301) 796-5450. Also, please conce 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
under the MDR regulation (2) "CF FCT at 005), products/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 I ou may 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
{4}------------------------------------------------
Indications for Use
510(K) Number (if known): _ L ( b 3 5 ]) CXDI-401G, CXDI-401C, CXDI-401G COMPACT, CXDI-401C COMPACT Device Name: Indications for Use: DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications. OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (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) Page 1 of 1 Division of Radiolo
§ 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.