(11 days)
Not Found
No
The description focuses on digital image capture and conversion, with no mention of AI, ML, or advanced image processing beyond basic display and transmission.
No.
The device is described as an X-ray digital camera intended for diagnostic procedures, which involves capturing images, not providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures."
No
The device description explicitly states it is a "Canon X-ray digital camera" and describes its function of capturing and converting X-ray images, which are hardware-based functions.
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. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that this device is an "X-ray Digital Camera" used for "digital image capture for conventional film/screen radiographic examinations." It captures images of the body using X-rays.
- Intended Use: The intended use is to "replace radiographic film/screen systems in all general-purpose diagnostic procedures," which are procedures involving imaging the internal structures of the body.
The device is a medical imaging device, specifically a digital radiography (DR) system, which is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DR-ER version of Canon's X-ray Digital Cameras 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 X-ray digital camera model CXDI-11 DR-ER add. version 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.
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
5 2002 NOV
Attachment 4
510(k) Summary
Prepared:
October 19, 2002
Submitter:
Company Name: Company Address:
Contact Person: Phone Number: Fax number:
Canon U.S.A., Inc. (U.S. agent/official correspondent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Sheila Driscoll, Senior Product Safety Engineer (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-11 DR-ER add. version MQB, Solid State X-ray Imager To be assigned
Predicate Device:
Manufacturer: Trade Name: Canon Model Name: CXDI-11 Classification Name: FDA 510(k)#: K981 256
Canon Inc. MQB, Solid State X-ray Imager
Description Of Device:
The Canon X-ray digital camera model CXDI-11 DR-ER add. version 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 X-ray Digital Camera CXDI-11 DR-ER add. version is substantially equivalent to the Canon X-ray Digital Camera CXDI-11.
Intended Use:
Canon X-ray digital camera CXDI-11/ CXDI-11 DR-ER add. version provide 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.
1
510(k) Summary
Prepared:
October 19, 2002
Submitter:
Company Name: Company Address:
Contact Person: Phone Number: Fax number:
Canon U.S.A., Inc. (U.S. agent/official correspondent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Sheila Driscoll, Senior Product Safety Engineer (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-22 DR-ER add. version MQB, Solid State X-ray Imager To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Namc: Classification Name: FDA 510(k)#:
Canon Inc. Canon CXDI-22 MQB, Solid State X-ray Imager K992547
Description Of Device:
The Canon X-ray digital camcra model CXDI-22 DR-ER add. version 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 capure for conventional film/screen radiographic examinations.
The Canon X-ray Digital Camera CXDI-22 DR-ER add. version is substantially equivalent to the Canon X-ray Digital Camera CXDI-22.
Intended Use:
Canon X-ray digital camera CXDI-22/ CXDI-22 DR-ER add. version provide 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.
-14-
2
510(k) Summary
Prepared:
October 19, 2002
Submitter:
Company Name: Company Address:
Contact Person: Phone Number: Fax number:
Canon U.S.A., Inc. (U.S. agent/official correspondent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Sheila Driscoll, Senior Product Safety Engineer (516) 328-5602 (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-31 DR-ER add. version MOB, Solid State X-ray Imager To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k)#:
Canon Inc. Canon CXDI-31 MQB, Solid State X-ray Imager K003689
Description Of Device:
The Canon X-ray digital camera model CXDI-31 DR-ER add. version 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 X-ray Digital Camera CXDI-31 DR-ER add. version is substantially equivalent to the Canon X-ray Digital Camera CXDI-31.
Intended Use:
Canon X-ray digital camera CXDI-31/ CXDI-31 DR-ER add. version provide 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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
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
Ms. Sheila Driscoll Senior Product Safety Engineer Canon U.S.A., Inc. One Canon Plaza LAKE SUCCESS NY 11042-1198
AUG 23 2013
Re: K023586
Trade/Device Name: DR-ER Version of Canon X-ray Digital Cameras Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 23, 2002 Received: October 25, 2002
Dear Ms. Driscoll:
This letter corrects our substantially equivalent letter of November 5, 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 of
4
Page 2
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
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | K023586 |
|---|---|
| Device Name | DR-ER Version of Canon X-ray Digital Cameras |
| Indications for Use | The DR-ER version of Canon's X-ray Digital Cameras 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 ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR .
Ermit A. Seppanen
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Device 23386 510(k) Number
-11-