(15 days)
Not Found
No
The description focuses on the digital image capture and conversion process, comparing it to a predicate device based on sensor material and image quality metrics (dosage, DQE). There is no mention of AI/ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as capturing and converting X-ray images for diagnostic purposes, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" states that the device "provides 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 clearly indicates its use in diagnostic processes.
No
The device description clearly states it is a digital radiography system that captures and converts X-ray images using hardware components like a CsI fluorescent screen and an amorphous silicon array. It also requires a Control PC to operate. This indicates it is a hardware device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Canon DIGITAL RADIOGRAPHY CXDI-40C is a digital radiography system. It captures and converts conventional X-ray images of the inside of the body to digital images. It does not analyze samples 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 refers to imaging the body directly with X-rays.
Therefore, the device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CANON DIGITAL RADIOGRAPHY CXDI-40C 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)
90 MQB
Device Description
The Canon digital radiography CXDI-40C 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-40C is different from CXDI-40G in the following respect.
- Both the CXDI-40C and the CXDI-40G use the same amorphous silicon alley as the . sensing means, however, the CXDI-40C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDL-40G. The CXDI-40C uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high x-ray absorption as fluorescent screen, CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G.
Since the same amorphous silicon array is used, the CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40C as well as CXDI-40G operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G.
Control PC is required to operate the CXDI-40C as well as the predicate devices.
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)
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.
0
Section 10: Summary Koz 1633 510(k) Summary
Prepared:
April 8, 2003
| 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 (516) 328-5169
Proposed Device:
Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: Regulation Number: FDA 510(k) #:
New Model Canon Inc. Canon CXDI-40C צו יורק // CXDI-40C MQB, Solid State X-ray Imager 892.1630 To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: Regulation Number: FDA 510(k) #:
Canon Inc. Canon CXDI-40G V 6, V MQB, Solid State X-ray Imager 892.1630 K023750
Description Of Device:
The Canon digital radiography CXDI-40C 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-40C is different from CXDI-40G in the following respect.
- Both the CXDI-40C and the CXDI-40G use the same amorphous silicon alley as the . sensing means, however, the CXDI-40C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXDL-40G. The CXDI-40C uses CsI (Cesium Iodide) while CXDI-40G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high x-ray absorption as fluorescent screen, CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G.
Since the same amorphous silicon array is used, the CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40C as well as CXDI-40G operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G.
1
KO31633
Section 10: Summary
Control PC is required to operate the CXDI-40C as well as the predicate devices.
Intended Use:
Canon digital radiography CXDI-40C 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.
Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40C described in this submission is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2003
Canon, Inc. % Ms. Susan Gill Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995
Re: K031633 Trade/Device Name: Digital Radiography Model CXDI-40C Regulation Number: 21 CFR 892.1630 Regulation Name: Solid state x-ray imaging system Regulatory Class: II Product Code: 90 MQB Dated: May 23, 2003 Received: May 27, 2003
Dear Ms. Gill:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xxx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 3: Statement
Indications Statement
Page | of
510(K)Number(if known): K031632
-40 C V 6.0 Device Name:
Indications for Use:
CANON DIGITAL RADIOGRAPHY CXDI-40C 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.
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF
OR
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
David A. Seppam
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