SEDECAL X PLUS LP PLUS

K062335 · Sedecal., Sa. · KPR · Sep 14, 2006 · Radiology

Device Facts

• Record ID: K062335
• Device Name: SEDECAL X PLUS LP PLUS
• Applicant: Sedecal., Sa.
• Product Code: KPR · Radiology
• Decision Date: Sep 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SEDECAL X PLUS LP PLUS Universal Radiographic Systems 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 for diagnostic radiographic exposures; utilizes high-frequency inverters; operates on 120/220V AC. Input: patient positioning for imaging; Output: radiographic images. Operated by qualified doctors or technicians in clinical settings. Modified device features software-driven touch panel LCD and infrared remote control for system operation. System supports various patient positions (sitting, standing, prone, supine). Benefits include improved user interface and control flexibility compared to legacy push-button systems.

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 the predicate device.

Technological Characteristics

Stationary X-ray system; high-frequency inverter; 120/220V 50-60Hz AC power. User interface: software-driven touch panel LCD and infrared remote. Performance standard: 21 CFR 1020.30. Electrical safety: UL 2601, IEC 60601-1.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, extremities, and other body parts. Patient may be sitting, standing, or lying (prone/supine).

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)

Submission Summary (Full Text)

{0}------------------------------------------------

K062335
Page 1 of 2

## 510(k) Summary

SEP 1 4 2006

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

July 20, 2006

1. Identification of the Device: Proprietary-Trade Name: SEDECAL X PLUS LP PLUS Universal Radiographic Systems Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR Common/Usual Name: General purpose diagnostic X-ray Unit.

- 2. Equivalent legally marketed devices: Sedecal URS X-Ray Units K012546.
- Indications for Use (intended use) The SEDECAL X PLUS LP PLUS Universal 3. Radiographic Systems 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: SEDECAL X PLUS LP PLUS Universal Radiographic Systems 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 employs new controls, including a touch screen and an infrared remote.
- 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.

{1}------------------------------------------------

K062335
Page 2 of 2

| Characteristic | Sedecal URS<br>K012546 | SEDECAL X PLUS<br>LP PLUS Universal<br>Radiographic<br>Systems |
|----------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use: | General purpose<br>diagnostic X-ray unit | SAME |
| Energy Source: | 120V,<br>230/240V(50/60Hz)<br>Line or Battery Power | SAME |
| User Interface | Depends on Control<br>Console option<br>chosen. Mainly<br>dedicated touch<br>controls | Software Driven<br>Touch Panel LCD, +<br>remote control unit |
| Maximum output | Depends on model of<br>generator chosen.<br>Models available from<br>30 kW to 64 kW | SAME as original<br>units. |
| Tube mount | Fixed with respect to<br>receptor, arm can<br>rotate. | Same |
| Receptor mount | Fixed on same<br>column as tube head | SAME |
| Method of Control | Dedicated push button<br>Controls | Software Driven<br>Touch Panel LCD,<br>remote control unit |
| Performance Standard | 21 CFR 1020.30 | SAME |
| Electrical safety: | UL 2601,<br>IEC 60601-1 | SAME |

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

:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 4 2006

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

Re: K062335

Trade/Device Name: SEDECAL X PLUS LP PLUS Universal Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: August 8, 2006 Received: August 16, 2006

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 adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, block-like font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the circle.

Protecting and Promoting Public Health

{3}------------------------------------------------

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 that I Dri has made a solations administered by other Federal agencies. You must of any I vith 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 CFR Part 8077, lacemig (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (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) I mis letter will and in Job is ong.
premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince notification " mesults 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 If you desire specific acrise to your of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21 CF F art 60 : 3 ). - 1 of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): _ KoL2335

Device Name: SEDECAL X PLUS LP PLUS Universal Radiographic Systems

Indications For Use:

Indications for Use: The SEDECAL X PLUS LP PLUS Universal Radiographic Systems 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)

Carolyn Y Newland

•

Page 1 of 1

(Division Sinch-Off Division of Reproductive, Abdominal and Rediological Devices 5 TO(k) Number ______________

EXHIBIT 2