(75 days)
Not Found
No
The summary describes basic digital image capture and processing (gray-scale optimization) but makes no mention of AI, ML, or related concepts. The focus is on replacing film/screen systems with digital technology.
No
The device is described as an X-ray digital camera for image capture and diagnostic procedures, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "all general purpose diagnostic procedures."
No
The device description explicitly states it is a "digital camera" and is used to "directly capture and convert conventional projection X-ray images to digital images," indicating it is a hardware device with integrated software.
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 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 describes an imaging device used for capturing images of the human body, not for testing samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description reinforces this by explaining how it captures and converts X-ray images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is an imaging device used for capturing anatomical structures.
N/A
Intended Use / Indications for Use
CANON X-RAY DIGITAL CAMERA CXDI-22 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
MQB
Device Description
The Canon X-ray digital camera model CXDI-22 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. Canon X-ray digital camera CXDI-22 is different from CXDI-11 in the following respect: · Model CXDI-11 operates in conjunction with an upright stand, while model CXDI-22 is a retrofit kit for installation into an existing radiologic 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 1 3 1999
K99 2547
510(k) Summary
CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 TELEPHONE (516) 328-5000 GENERAL FAX TELEPHONE (516) 328-5009
Prepared:
an
July 19, 1999
Submitter:
Canon USA, Inc. (U.S. designated agent for Canon Inc.) Company Name: Company Address: One Canon Plaza Lake Success, NY 11042 Ken Shadoff, Senior Product Safety Engineer Contact Person: (216) 328-5602 Phone Number: (516) 328-5169
Proposed Device:
Fax Number:
| Reason For 510(k): | New Model |
|---|---|
| Manufacturer: | Canon Inc. |
| Trade Name: | Canon |
| Model Name: | CXDI-22 |
| 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 |
| Classification Name: | 90MQB, Solid State X-ray Image |
| FDA 510(k) #: | K981556 |
Description Of Device:
The Canon X-ray digital camera model CXDI-22 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.
Canon X-ray digital camera CXDI-22 is different from CXDI-11 in the following respect:
- · Model CXDI-11 operates in conjunction with an upright stand, while model CXDI-
- 22 is a retrofit kit for installation into an existing radiologic table.
Intended Use:
Canon X-ray digital camera CXDI-22 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.
1
Table of comparison
| Item | CXDI-11 | CXDI-22 | |
|---|---|---|---|
| Intended Use | Provide diagnostic images for general radiography with upright system | Provide diagnostic images for general radiography with table system | |
| Desgin | Digital acquisistion, electronic processing | Same | |
| Energy Uses | Receives x-radiation generated by external x-ray generator | Same | |
| Materials | X-ray Absorber | Fluorescent screen( $Gd_2O_2S:TB^{3+}$ ) | |
| Visible emission peak: 545nm | Same | ||
| Sensing Means | Amorphous Silicon W/TFT Array Detection peak:540-620nm | Same | |
| Anatomical Sites | General radiography | Same | |
| Target Population | General population | Same | |
| Physical Safety | Minimize exposure to x-radiation | Same | |
| Compliance with Standard | Complies with IEC 601-1-2 | Same | |
| Biocompatibility | N/A | N/A | |
| Performance | After digital processing(optimize the gray-scale) | Same | |
| Labeling | Approved 510(K) | See attachment labeling | |
| MTF | MTF@2lp/mm 42% | Same | |
| Dynamic Range | Dyanamic range: | ||
| approximately 4 digit | |||
| (linear A/D : 14bit) | |||
| (output data : 12bit) | Same | ||
| Sensor Unit | 552 x 598 x 231mm | 604 x 645 x 73.5or69mm | |
| Power Supply | 580 x 489 x 275mm | 390 x 160 x 110mm | |
| Control PC | 483.5 x 594 x 300mm | 453 x 594 x 300mm | |
| Operation Unit | 298 x 209.5 x 130mm | Same | |
| Card Reader | 50 x 180 x 39mm | Same | |
| Stand | 900 x 475 x 2100mm | N/A | |
| Table | N/A | N/A |
:
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 emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, sans-serif font. The emblem features a stylized representation of a human figure within a circular border.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ken Shadoff Senior Product Safety Engineer Canon USA. Inc. One Canon Plaza LAKE SUCCESS NY 11042-1198
AUG 23 2013
Re: K992547
Trade/Device Name: Model CXDI-22 X-ray Digital Camera Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 29, 1999 Received: July 30, 1999
Dear Mr. Shadoff:
This letter corrects our substantially equivalent letter of October 13, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 510(x) promants is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed interstate for use stated in the encrosule) to regary manated to the Medical Device Amendments, or to commerce prior to May 20, 1970, the character with the provisions of the Federal Food, Drug, devices that nave been recials in accorded in accorded approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosmelle Act (Act) that do not require apple on the general controls provisions of the Act. The You may, defector, market the device, sayler to increasents for annual registration, listing of
general controls provisions of the Act include requirements for annual registr general controls provisions of the fict mention 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 above) into enose (ope your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Code of Poucharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that FDA s issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA lias made a decemmation that your seered by other Federal agencies. You must a or any Peteral statules and regulations adminities, but not limited to: registing (21)
comply with all the Act's requirements, including, but not limited to secting of comply with all the Act 3 requirements, incrueing, Strates call device reporting (reporting of
3
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related aurelse ovense (OS) regulation (21 CFR Part 820). This letter requirements as set forur in the quality of the as described in your Section 510(k) prematet will allow you to begin marketing your active af your device to a legally marketed nothication. The FDA midnig of backan 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 If you desire specific advice for your device of the Evaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device Eyaluation and arcrease 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 1450. Also, please note the regulations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 CFR Pat 005), promo go go 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
4
Indications Statement
K992547 510(K)Number(if known):
CKDI-22 Device Name:
Indications for Use:
CANON X-RAY DIGITAL CAMERA CXDI-22 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.
NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT NEEDE
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Page
of
David A. Syverson
OR
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number
ರ್ಥಿಗಳು