RADPRO ION

K083725 · Virtual Imaging, Inc. · OWB · Jan 22, 2009 · Radiology

Device Facts

• Record ID: K083725
• Device Name: RADPRO ION
• Applicant: Virtual Imaging, Inc.
• Product Code: OWB · Radiology
• Decision Date: Jan 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Indications for Use

The RadPro ION Mobile Fluoroscopy Systems are designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures The system may be used for other imaging applications at the physician's dıscretion

Device Story

RadPro ION Mobile Fluoroscopy Systems are mobile C-arm X-ray units used in surgical, orthopedic, traumatology, and cardiology settings. The system captures X-ray images using an image intensifier and a high-contrast CCD camera. It features image rotation and reversal capabilities. An automatic dose control system adjusts kV and mA values based on patient thickness and density to minimize radiation exposure. The system includes a control panel with an alphanumerical display, which can be extended via cable to the patient support for operator control. Images are stored and displayed in real-time on a monitor. The device incorporates a Dose Area Product (DAP) meter for regulatory compliance. Physicians and clinical staff use the system to visualize internal structures during procedures, facilitating real-time clinical decision-making and diagnostic accuracy while managing radiation dose.

Clinical Evidence

Bench and laboratory testing were performed to verify performance against applicable standards. No clinical trial data was required or presented; substantial equivalence was supported by bench testing and evaluation of clinical images.

Technological Characteristics

Mobile C-arm X-ray system; 18 kW generator; 9" or 13" image intensifiers; CCD camera with image rotation/reversal; automatic dose control (kV/mA modulation); Dose Area Product (DAP) meter; alphanumerical control console; electrical safety per IEC-60601; UL listed.

Indications for Use

Indicated for patients undergoing diagnostic, surgical, or interventional procedures requiring fluoroscopic or spot-film imaging, including cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care, and emergency room applications.

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

• OEC 9900 Elite (K073543)

Submission Summary (Full Text)

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510(k) Summary 510(k) Number KOS3 725 Virtual Imaging, Inc. 720 S. Powerline Road, Suite E Deerfield Beach, FL 33442 954-428-6191 (Office) 954-428-6195 (Fax) Chris Duca, Chief Operating Officer Contact: Date Prepared: November 6, 2008

- l Identification of the Device: Proprietary-Trade Name: RadPro ION Mobile Fluoroscopy Systems (Multiple Models) Classification Name/Product Codes: Image Intensified Fluoroscopic System, JAA, Mobile X-Ray, IZL Common/Usual Name: Mobile Fluoroscopic X-Ray System
- Equivalent legally marketed device K073543 OEC 9900 Elite, GE Healthcare 2
- Indications for Use (intended use) The RadPro ION Mobile Fluoroscopy Systems are 3 designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures The system may be used for other imaging applications at the physician's dıscretion
- Description of the Device The RadPro ION Mobile Fluoroscopy Systems (Multiple 4 Models) are mobile x-ray units which employ unage intensifier units and have various options for image display and storage The units are used to equip a radiological room of general surgery, orthopedic, traumatology and cardiology The CCD camera is characterized by high contrast and sensitivity and no persistence of image The camera head include a mage rotation and image reversal system The automatic dose control, which acts either on KV and mA values, allows the user to reduce step by step the x-ray radiation to the minimum value, in accordance with the thickness and the density of the screened part All the configurations can accept connection to a digital memory, which allows to store and display in real time the ımage on the monitor only with a very little x-ray dose The new control panel with an alphanumerical display permits a fast and easy use by a rational and simple symbology, this console by an extension cable, could be located on the patient support to enable the c-arm control by the operator itself The system employs a Dose Area Product (DAP) meter for compliance with the US performance standard requirements
- ર Safety and Effectiveness, comparison to predicate device The results of bench and test laboratory testing indicate that the new device is as safe and effective as the predicate devices

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| 6. Substantial Equivalence Chart | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Characteristic | K073543 OEC 9900 Elite, GE Healthcare | RadPro ION Mobile Fluoroscopy Systems |
| Intended Use | The OEC 9900 Elite Mobile Fluoroscopy<br>Systems are designed to provide fluoroscopic<br>and spot-film images of the patient during<br>diagnostic, surgical and interventional<br>procedures Examples of clinical application<br>may include cholangiography, endoscopy,<br>urologic, orthopedic, neurologic, critical care<br>and emergency room procedures The system<br>may be used for other imaging applications at<br>the physician's discretion | SAME |
| Configuration | Mobile C-Arm | SAME |
| Performance Standard | 21 CFR 1020 30 | SAME |
| Generator | 15 kW | 18 kW |
| Power Source | 120 VAC 1 phase 20 amp | SAME |
| Image Intensifiers | 9" or 12" | 9" or 13" |
| Electrical safety | Electrical Safety per IEC-60601 UL listed | SAME |

## Substantial Equivalonco Cha

## 7. Conclusion

1

After analyzing bench and external laboratory testing to applicable standards, as well as clinical ımages, it is the conclusion of Virtual Imaging, Inc that the RadPro ION Mobile Fluoroscopy Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing wings or feathers.

Food and Drug Admınıstration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2009

Virtual Imaging, Inc % Daniel Kamm, P E Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re K083725

Trade/Device Name RadPro ION Mobile Fluoroscopy Systems (Multiple Models) Regulation Number 21 CFR 892 1650 Regulation Name Image-intensified fluoroscopic x-ray system Regulatory Class II Product Code JAA Dated December 12, 2008 Received December 16, 2008

## Dear Mr Kamm

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 adulterat10n

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition, FDA may publish further announcements concerning your device in the Federal Register

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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 Part 801, good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding os 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter

| 21 CFR 876 xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892 xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveyllance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry suppot/index html

Sincerely yours,

Janine M. Norris

anıne M N Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K08372-5

Device Name RadPro ION Mobile Fluoroscopy Systems (Multiple Models)

Indications For Use

The RadPro ION Mobile Fluoroscopy Systems are designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures Examples of clinical application may include cholangrography, endoscopy, urologic, orthopedic, neurologic, crtical care and emergency room procedures The system may be used for other imaging applications at the physician's discretion

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)

Division Sign-Off

(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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