(66 days)
No
The summary describes a digital radiography system that converts X-ray images into digital signals. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of these technologies. The performance studies focus on safety, effectiveness, and substantial equivalence to predicate devices, without mentioning any AI/ML-specific performance metrics or training/test data.
No.
This device is designed to generate fluoroscopic images for diagnostic and interventional procedures, not to provide treatment.
Yes
The device is explicitly indicated for diagnostic procedures in vascular angiography and cardiology. It also generates fluoroscopic images of human anatomy, which are used for diagnosis.
No
The device description explicitly states it is a "portable digital radiography" unit that "directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images." This indicates the device includes hardware components (sensor, conversion unit) beyond just 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 is used for generating fluoroscopic images of human anatomy for various medical procedures (vascular angiography, cardiology, diagnostic, and interventional). This involves imaging the inside of the body, not analyzing samples taken from the body.
- Device Description: The description details how the device captures X-ray images and converts them into digital signals. This is a process of medical imaging, not in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a medical imaging system used to visualize the internal structures of the body directly.
N/A
Intended Use / Indications for Use
The URS-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Product codes
OWB, JAA, 121
Device Description
The Canon Dynamic/Static DR URS-50RF is a portable digital radiography that can take images of any part of the body.. It directly converts the X-ray images captured by the LANMIT (Large Area New MIS Sensor and TFT) sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
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)
Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially.equivalent to the predicate device. Tests include: Performance testing and Software Validation. Electrical safety and Electromagnetic Compatibility testing has been performed. The unit complies with the US Performance Standard for radiographic equipment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Siemens AXIOM Luminos dRF, K062623, GE Innova 4100, K023178/K091658, Canon CXDI-50C K060433, Sedecal X-PLUS LP Plus Digital Diagnostic X-Ray Systems K090238 and Canon Dynamic/Static DR Model CXDI-50RF, K092439
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) SUMMARY
FEB - 4 2010
Image /page/0/Picture/3 description: The image shows the logo for Virtual Imaging, which is a Canon USA company. The logo features a stylized "V" inside a square on the left. To the right of the square is the text "VIRTUAL IMAGING" in a bold, sans-serif font. Below the company name is the text "A CANON USA Company".
Image /page/0/Picture/4 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are filled with a dark color, possibly black or a dark shade of gray. The overall impression is a clear and recognizable depiction of the Canon logo or brand name.
720 S. Powerline Road, Suite E Deerfield Beach, FL 33442 954-428-6191 (Office) 954-428-6195 (Fax)
Page 1 of 2, 510(k) Summary: Canon Dynamic/Static DR Fluoroscopic Digital X-Ray System .
Model URS-50RF
| Date Prepared | October 30, 2009 |
|---|---|
| Summary prepared by: | Chris Duca, Chief Operating Officer |
| Device Name | Canon Dynamic/Static DR |
| Fluoroscopic Digital X-Ray System | |
| Trade Name | Model URS-50RF |
| Common Name | Fluoroscopic Digital X-Ray System |
| Classification | Class: II |
| Product Code: OWB, JAA, 121 | |
| Regulation: 21 CFR § 892.1650 | |
| Identification of | |
| Predicate Devices and | |
| Summary of Substantial | |
| Equivalence | Siemens AXIOM Luminos dRF, K062623, GE Innova 4100, |
| K023178/K091658, Canon CXDI-50C K060433, Sedecal X-PLUS LP | |
| Plus Digital Diagnostic X-Ray Systems K090238 and Canon | |
| Dynamic/Static DR Model CXDI-50RF, K092439 | |
| Device Description | The Canon Dynamic/Static DR URS-50RF is a portable digital |
| radiography that can take images of any part of the body.. | |
| It directly converts the X-ray images captured by the LANMIT | |
| (Large Area New MIS Sensor and TFT) sensor into a high-resolution | |
| digital images. The instrument is suited for use inside a patient | |
| environment. This unit converts the X-rays into digital signals. The | |
| unit can acquire still and moving images. |
1
Page 2 of 2, 510(k) Summary: Canon Dynamic/Static DR Fluoroscopic Digital X-Ray System Model URS-50RF
| Intended Use and
Indications | The URS-50RF is indicated for use in generating fluoroscopic
images of human anatomy for vascular angiography, diagnostic
and interventional procedures. It is also indicated for generating
fluoroscopic images of human anatomy for cardiology, diagnostic,
and interventional procedures. It is intended to replace
fluoroscopic images obtained through image intensifier
technology. Not intended for mammography applications. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological | |
| Characteristics and | Comparison with the predicate shows the technological |
| | characteristics of the URS-50RF are equal to or better than the |
| Substantial Equivalence | predicate device. The units are functionally identical. |
| Performance
Testing/Data | Tests were performed on the device which demonstrated that the
device is safe and effective, performs comparably to and is
substantially.equivalent to the predicate device.
Tests include: Performance testing and Software Validation.
Electrical safety and Electromagnetic Compatibility testing has
been performed. The unit complies with the US Performance
Standard for radiographic equipment. |
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. .•••••.
2
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
Virtual Imaging, Inc. % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8726 Ferrara Ct. NAPLES FL 34114
JUL 30 2012
Re: K093688
Trade/Device Name: Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and IZI Dated: November 24, 2009 Received: December 2, 2009
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of February 4, 2010.
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
3
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. Morri
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): K09368 Device Name: Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System
The URS-50RF is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for grone ating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
Page 16 of 1181