SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR

K043002 · Sedecal., Sa. · IZL · Nov 18, 2004 · Radiology

Device Facts

• Record ID: K043002
• Device Name: SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR
• Applicant: Sedecal., Sa.
• Product Code: IZL · Radiology
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Sedecal Mobile 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.

Device Story

Mobile X-ray system; combines Sedecal mobile X-ray unit with Canon CXDI-50G digital detector. Inputs: X-ray radiation; outputs: digital radiographic images. Operated by qualified doctors/technicians in clinical settings. Device utilizes high-frequency inverters; controlled via color LCD touch panel. Serial port connection between X-ray generator and digital detector allows integrated operation. Healthcare providers use images for diagnostic assessment of various body parts. Benefits include mobile diagnostic capability for patients unable to be transported to fixed imaging suites.

Clinical Evidence

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

Technological Characteristics

Mobile X-ray unit; 120/220V AC or battery powered; high-frequency inverter. Digital detector resolution: 160 x 160 micron pixel pitch, ~6 million pixels, 4,096 gray scale. User interface: color LCD touch panel. Compliance: 21 CFR 1020.30, IEC 60601-1.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Suitable for patients in sitting, standing, prone, or supine positions. No specific contraindications listed.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Sedecal Mobile X-Ray Units (K012663)
• Canon CXDI-50G Digital Radiography (K031447)

Submission Summary (Full Text)

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Koysaooz

## NOV 1 8 2004

| 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 | | | |

EXHIBIT 2

October 22, 2004

- 1. Identification of the Device: Proprietary-Trade Name: Sedecal Mobile Radiographic Systems with Digital Detector Classification Name: Mobile X-ray system, Product Codes Product Code 90 IZL and MOB Common/Usual Name: General purpose mobile diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: Sedccal Mobile X-Ray Units K012663 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units.
- 3. Indications for Use (intended use) The Sedecal Mobile 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.
- 4. Description of the Device: Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays 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.
- 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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| Characteristic | Model Mobile<br>K012663 (Two<br>models) | Canon CXDI-50G<br>Digital<br>Radiography,<br>K031447 | Sedecal Mobile X-<br>ray Units with Detector<br>(Combination<br>device) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use: | Mobile general purpose<br>diagnostic X-ray unit | SAME | SAME |
| Size | | Imaging Area 14 x 17 | SAME (Combined<br>device) (A stand has<br>been added) |
| Weight (battery version) | 1045 lb | 10.6 lb | 964 lb. |
| Energy Source: | 90 to 285 VAC (50-60<br>Hz) or Batteries | 100V, 120V,<br>230/240V(50/60Hz) | SAME (Combined<br>device) |
| User Interface | Up-Down pushbuttons<br>for kVp and mAs. KVp<br>adjustable in I kVp<br>steps | Software Driven Touch<br>Panel LCD | Software Driven Touch<br>Panel LCD (Combined<br>device) |
| Power | 20 or 30 kW | N/A | Models up to 50 kW |
| Exposure times | 0.001 - 8 SECONDS<br>$\pm$ (1%+0.1 MS) | N/A | SAME (Combined<br>device) |
| Ma. | 10, 12.5, 16, 20, 25, 32,<br>40, 10, 12.5, 16, 20, 25,<br>32, 40, 50, 64, 80, 100,<br>125, 160, 50, 64, 80,<br>100, 125, 160, 200, 250,<br>320 200, (400, and 500<br>on 30 kw unit)<br>$\pm$ (5%+0.1 MA) | N/A | SAME (Combined<br>device) |
| kVp | 40 to 150 in 1 kVp steps<br>(30 kw unit) | N/A | SAME (Combined<br>device) |
| Resolution | N/A | 160 x 160 microns pixel<br>pitch, with<br>approximately 6 million<br>pixels and 4,096 gray<br>scale contrast | SAME (Combined<br>device) |
| Method of Control | Dedicated Touch Panel | Software Driven Touch<br>Panel LCD | SAME as CANON. Or<br>original Dedicated<br>Touch Panel |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | IEC 60601-1 | SAME | 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 Mobile X-ray Units with Digital 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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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

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

AUG 23 2013

Re: K043002

Trade/Device Name: Sedecal Mobile X-Ray Units with Digital Detector Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: October 27, 2004 Received: November 1, 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 (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. 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):_____________________________________________________________________________________________________________________________________________________

Device Name: Sedecal Mobile X-Ray Units with Digital Detector

Indications For Use:

The Sedecal Mobile 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)

David A. Bergman

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