FLUOROPRO RF DIGITAL IMAGING SYSTEM

K070390 · Virtual Imaging, Inc. · JAA · Apr 5, 2007 · Radiology

Device Facts

• Record ID: K070390
• Device Name: FLUOROPRO RF DIGITAL IMAGING SYSTEM
• Applicant: Virtual Imaging, Inc.
• Product Code: JAA · Radiology
• Decision Date: Apr 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

Device Story

FluoroPro RF Digital Imaging System is a high-resolution digital imaging system for fluoroscopy, interventional fluoroscopy, angiography, and cardiac imaging. It replaces conventional film techniques. The system captures fluoroscopic signals via a TV camera and Thales CCD; processes images using an internal image processor; and displays them on monitors. Operators view and enhance 1000-line fluoroscopy; acquire high-resolution digital spot images (1024 x 1024) at rates up to 30 fps. Images are stored locally or transmitted via network for long-term storage; hardcopies produced via laser printer. Used in clinical settings by physicians or technicians to visualize diagnostic details, enabling clinical decision-making through enhanced image clarity.

Clinical Evidence

Bench testing and user testing only. No clinical trial data provided. Testing confirmed performance equivalence to the predicate device regarding image acquisition, resolution, and safety standards.

Technological Characteristics

Digital fluoroscopic x-ray system; Thales CCD sensor; 1024 x 1024 12-bit digital resolution; 120 VAC 50/60 Hz power; DICOM file compatibility; includes fluoroscopic TV camera, monitors, and image processor; supports up to 30 fps acquisition.

Indications for Use

Indicated for adult and pediatric patients requiring fluoroscopic radiographic imaging of the skull, spinal column, chest, abdomen, extremities, and other body parts. To be used by qualified clinicians or technicians.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Infimed Orion Digital Imaging System (K012490)

Submission Summary (Full Text)

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K070390

APR 5 - 2007

EXHIBIT 2 S10(k) Summar

Image /page/0/Picture/3 description: The image shows the words "VIRTUAL IMAGING" in bold, sans-serif font. The words are stacked on top of each other, with "VIRTUAL" on the top line and "IMAGING" on the bottom line. To the left of the words is a black and white graphic that is partially obscured. The graphic appears to be a logo or symbol of some kind.

720 S. Powerline Road Suite E Deerfield Beach, FL 33442 954-428-6191 (Office) 954-428-6195 (Fax) January 18, 2007 Contact: Chris Duca, COO

- l. Identification of the Device: Proprietary-Trade Name: FluoroPro RF Digital Imaging System Classification Name: System, x-ray, fluoroscopic, image-intensified Product Code Product Code JAA and LLZ. Common/Usual Name: Fluroscopic X-Ray System
- 2. Equivalent legally marketed device: Infimed Orion Digital Imaging System, K012490 (Now called PlatinumOne RF)..
- 3. Indications for Use (intended use) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts. .
- Description of the Device: The FluoroPro RF Digital Imaging System is a high resolution, ব digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The FluoroPro RF Digital Imaging System allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1024) may be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The FluoroPro RF Digital Imaging System enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor ..
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

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| Characteristic | Infimed Orion<br>Digital Imaging<br>System, K012490<br>(Now called<br>PlatinumOne RF). | FluoroPro RF<br>Digital Imaging<br>System |
|-------------------------|----------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use: | Acquisition, display,<br>storage and<br>transmission of<br>fluoroscopic images | SAME |
| Power source | 120 VAC 50/60 HZ<br>7 amps | 120 VAC 50/60 HZ<br>2.5 amps |
| Image acquisition | Up to 15 FPS (spot),<br>up to 30 fps (fluoro) | SAME |
| File compatibility | DICOM | SAME |
| CCD | Innovision CCD | Thales CCD |
| Digital Resolution | 1024 x 1024 12 bit | SAME |
| Performance<br>Standard | US FDA | SAME |
| Electrical safety | SAME | SAME |

## 6. Substantial Equivalence Chart, "FluoroPro RF Digital Imaging System"

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Virtual Imaging that the FluoroPro RF Digital Imaging System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold and is left-aligned. The words are all capitalized. The text is likely part of a document or letterhead.

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 Principal Consultant Kamm & Associate PO Box 7007 DEERFIELD IL 60015

AUG 21 2013

Re: K070390

Trade/Device Name: FluoroPro RF Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 2, 2007 Received: February 9, 2007

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of April 5, 2005.

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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known): K070 390

Device Name: FluoroPro RF Digital Imaging System

Indications For Use:

Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts.

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)

Daniel A. Ingram

Division Sign-Off Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number

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