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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canon Dynamic/Static DR Model URS-50RF Fluoroscopic Digital X-Ray System:

Summary of Device and Study Information (K093688)

This 510(k) summary describes a fluoroscopic digital X-ray system, the Canon Dynamic/Static DR URS-50RF, intended to generate fluoroscopic images for vascular angiography, diagnostic and interventional procedures, and cardiology. It aims to replace image intensifier technology. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary. For medical devices, particularly those establishing substantial equivalence, explicit "acceptance criteria" are often phrased in terms of meeting or exceeding the performance of legally marketed predicate devices, or complying with relevant standards. The document does not list specific numerical acceptance criteria for image quality, diagnostic accuracy, or clinical endpoints. Instead, it makes a general statement about performance.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied/stated)	Reported Device Performance
Safety & Effectiveness	Device is safe and effective	Device demonstrated safe and effective operation.
Performance Comparability	Device performs comparably to predicate devices	Device performs comparably to predicate devices.
Substantial Equivalence	Device is substantially equivalent to predicate devices	Device is substantially equivalent to predicate devices.
Technological Characteristics	Technological characteristics are equal to or better than predicate devices	Technological characteristics are equal to or better than predicate devices, and units are functionally identical.
Electrical Safety	Compliance with relevant electrical safety standards	Electrical safety testing performed, unit complies with US Performance Standard for radiographic equipment.
Electromagnetic Compatibility (EMC)	Compliance with relevant EMC standards	Electromagnetic Compatibility testing performed.
Software Validation	Software is validated	Software Validation performed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Tests were performed on the device," but does not specify the number of cases, images, or subjects used for performance testing.
Data Provenance: Not specified. It's unclear if the testing involved human subjects, phantoms, or simulated data, or the country of origin of any data used. Given the nature of a 510(k) for an imaging device, it's highly probable that bench testing with phantoms and potentially some limited clinical evaluation (if required to show equivalence for image quality) was involved, but details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. With no mention of expert review or ground truth establishment, no adjudication method is detailed.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or implied in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to already marketed devices based on technological characteristics and general performance testing, rather than a direct comparison of physician performance with and without AI assistance.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study (or AI assistance) was described.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: This device is a hardware fluoroscopic digital X-ray system, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study does not apply in this context. The performance described relates to the entire system's ability to acquire and process images.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. The performance testing is generally described as validating that the device is "safe and effective" and "performs comparably" to predicate devices. For an imaging system, ground truth might involve:
- Physical Measurements: Using phantoms to verify spatial resolution, contrast resolution, noise, dose efficiency, etc.
- Clinical Image Quality Assessment: Expert review of images to ensure diagnostic interpretability, though this isn't detailed as "ground truth" establishment in the psychological sense.
- Comparison to Predicate: Performance is often benchmarked against images from the predicate device.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware imaging system, not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a hardware device.

Summary

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K093688

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 DRFluoroscopic Digital X-Ray System
Trade Name	Model URS-50RF
Common Name	Fluoroscopic Digital X-Ray System
Classification	Class: IIProduct Code: OWB, JAA, 121Regulation: 21 CFR § 892.1650
Identification ofPredicate Devices andSummary of SubstantialEquivalence	Siemens AXIOM Luminos dRF, K062623, GE Innova 4100,K023178/K091658, Canon CXDI-50C K060433, Sedecal X-PLUS LPPlus Digital Diagnostic X-Ray Systems K090238 and CanonDynamic/Static DR Model CXDI-50RF, K092439
Device Description	The Canon Dynamic/Static DR URS-50RF is a portable digitalradiography 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-resolutiondigital images. The instrument is suited for use inside a patientenvironment. This unit converts the X-rays into digital signals. Theunit can acquire still and moving images.

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Page 2 of 2, 510(k) Summary: Canon Dynamic/Static DR Fluoroscopic Digital X-Ray System Model URS-50RF

Intended Use andIndications	The URS-50RF is indicated for use in generating fluoroscopicimages of human anatomy for vascular angiography, diagnosticand interventional procedures. It is also indicated for generatingfluoroscopic images of human anatomy for cardiology, diagnostic,and interventional procedures. It is intended to replacefluoroscopic images obtained through image intensifiertechnology. 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.
PerformanceTesting/Data	Tests were performed on the device which demonstrated that thedevice is safe and effective, performs comparably to and issubstantially.equivalent to the predicate device.Tests include: Performance testing and Software Validation.Electrical safety and Electromagnetic Compatibility testing hasbeen performed. The unit complies with the US PerformanceStandard for radiographic equipment.

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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

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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

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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

Regulation Number and Section

§ 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.