URS LP DIGITAL, MILLENNIUM, RADPRO

K042876 · Sedecal., Sa. · KPR · Nov 18, 2004 · Radiology

Device Facts

• Record ID: K042876
• Device Name: URS LP DIGITAL, MILLENNIUM, RADPRO
• Applicant: Sedecal., Sa.
• Product Code: KPR · Radiology
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Device Story

Stationary X-ray system; utilizes high-frequency inverters; operates on 120/220V AC. Combines Sedecal URS X-ray generator with Canon CXDI-50G digital detector via common color LCD touch panel interface. Generator controlled via serial port on detector. Provides additional mounting options for tube head (column/ceiling) and receptor (wall/table). Operated by qualified physicians or technicians in clinical settings. Produces digital radiographic images for diagnostic assessment of skeletal and soft tissue structures. Enhances workflow through integrated touch-panel control and flexible positioning.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technical specifications, performance standards (21 CFR 1020.30), and electrical safety testing (UL 2601, IEC 60601-1) against predicate devices.

Technological Characteristics

Stationary X-ray system; high-frequency inverter generator; 120/220V AC power. Digital detector with 160-micron pixel pitch, 6 million pixels, 4,096 gray scale contrast. User interface: color LCD touch panel. Mounting: column, ceiling, wall, and table options. Electrical safety: UL 2601, IEC 60601-1. Performance: 21 CFR 1020.30.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Procedures performed with patient in sitting, standing, prone, or supine positions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sedecal URS X-Ray Units (K012546)
• Canon CXDI-50G Digital Radiography (K031447)

Submission Summary (Full Text)

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## EXHIBIT 2 510(k) Summary

| SEDECAL SA --<br>Pelaya 9- Poligono Industrial Rio De<br>Janeiro<br>28110-Algete<br>Madrid Spain<br>Tel [phone]<br>Fax [phone]<br>(Foreign Manufacturer) | SEDECAL USA, Inc.<br>2910 N. Arlington Heights Rd.<br>Arlington Heights Illinois 60006<br>Tel [phone]<br>Fax [phone]<br>(Initial Importer)<br>Contact: Devan Moser |
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October 13, 2004

- 1. Identification of the Device: Proprietary-Trade Name: URS LP/Millennium/RadPro X-ray Units with Detector Classification Name: Mobile X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: Sedecal URS X-Ray Units K012546 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units.
- 3. Indications for Use (intended use) The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
- 4. Description of the Device: URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

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6. Substantial Equivalence Chart, The Sedecal Portable X-ray Units with Detector

| Characteristic | Sedecal URS<br>K012546 | Canon CXDI-50G<br>Digital<br>Radiography,<br>K031447 | URS LP/<br>Millennium/<br>RadPro X-ray Units<br>with Detector<br>(Combination<br>device) |
|----------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended Use: | General purpose<br>diagnostic X-ray unit | SAME | SAME |
| Energy Source: | 120V,<br>230/240V(50/60Hz)<br>Line or Battery Power | 100V, 120V,<br>230/240V(50/60Hz) | SAME (Combined<br>device) |
| User Interface | Depends on Control<br>Console option<br>chosen. Mainly<br>dedicated touch<br>controls | Software Driven<br>Touch Panel LCD | Software Driven<br>Touch Panel LCD |
| Maximum output | Depends on model of<br>generator chosen.<br>Models available from<br>30 kW to 64 kW | N/A | SAME as original<br>units. |
| Tube mount | Fixed with respect to<br>receptor, arm can<br>rotate. | | Additional mounting<br>options:<br>Column mount, and<br>ceiling mount options<br>now available. |
| Receptor mount | Fixed on same<br>column as tube head | N/A | Wall mount and table<br>mount now available |
| Digital Resolution | N/A | 160 x 160 microns<br>pixel pitch, with<br>approximately 6<br>million pixels and<br>4,096 gray scale<br>contrast | SAME (Combined<br>device) |
| Method of Control | Dedicated push button<br>Controls | Software Driven<br>Touch Panel LCD | Software Driven<br>Touch Panel LCD |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | UL 2601,<br>IEC 60601-1 | SAME | SAME |

## 7. Conclusion

After analyzing bench, user, and standards testing data, it is the conclusion of Sedecal that the Sedecal Portable X-ray Units with Detector are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

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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

SEDECAL SA % Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

AUG 20 2013

Re: K042876

Trade/Device Name: URS LP/Millennium/RadPro X-Ray Units with Digital Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: October 13, 2004 Received: October 19, 2004

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of November 18, 2004.

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 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):_

Device Name: URS LP/Millennium/RadPro X-Ray Units with Digital Detector

Indications For Use:

Indications for Use: The URS LP/Millennium/RadPro Radiographic Systems with Digital Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

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)

Nancy C. Brogdon

and Radiological Devic 510kl Nun

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