DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D

K042361 · Sedecal USA, Inc. · IZL · Sep 29, 2004 · Radiology

Device Facts

• Record ID: K042361
• Device Name: DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
• Applicant: Sedecal USA, Inc.
• Product Code: IZL · Radiology
• Decision Date: Sep 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Sedecal Portable X-ray 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

Portable X-ray unit combining high-frequency generator with digital radiography detector; operates on 120V AC. Input: X-ray exposure parameters (kVp, mAs) set via color LCD touch panel or pushbuttons. Transformation: High-frequency inverter generates X-rays; digital detector captures radiographic images. Output: Diagnostic radiographic images displayed for clinician review. Used in clinical settings by physicians or technicians. Output facilitates diagnostic decision-making for various body parts. Benefits: Portable diagnostic imaging capability for patients in diverse positions.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were established through comparison of technical specifications, performance standards, and user testing against predicate devices.

Technological Characteristics

Portable X-ray system; high-frequency inverter; 120V 50-60Hz power. Digital detector resolution: 160 x 160 micron pixel pitch, 4,096 gray scale contrast. User interface: Color LCD touch panel or dedicated pushbuttons. Electrical safety: UL 2601, IEC 60601-1. Regulatory compliance: 21 CFR 1020.30.

Indications for Use

Indicated for use by qualified physicians or technicians on adult and pediatric patients for diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities in sitting, standing, or recumbent positions.

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 Portable X-Ray Units (K020435)
• Canon CXDI-50G Digital Radiography (K031447)

Submission Summary (Full Text)

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SEP 2 9 2004

K042361
Page 1 of 2

### EXHIBIT 2 510(k) Summary

| 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) | |

August 24, 2004

- 1. Identification of the Device: Proprietary-Trade Name: SPS-HF-4.0-D Portable X-ray Units with Detector Classification Name: Mobile X-ray system, Product Codes 90 IZL and MQB Common/Usual Name: Portable general purpose diagnostic X-ray Unit.
- 2. Equivalent legally marketed devices: Sedecal Portable X-Ray Units K020435 and Canon CXDI-50G Digital Radiography, K031447. The MODIFIED device COMBINES these two units.
- 3. Indications for Use (intended use) The Sedecal Portable X-ray 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: SPS-HF-4.0-D Portable X-ray Unit with Detector is a portable unit which operate from 120 V 50-60~ AC. The unit utilizes a high frequency inverter mounted to a tripod or support arm. 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.
- 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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K042361
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| Characteristic | Model SP-HF-4.0<br>K020435 | Canon CXDI-50G<br>Digital<br>Radiography,<br>K031447 | Sedecal SPS-HF-<br>4.0-D Portable X-<br>ray Units with<br>Detector<br>(Combination<br>device) |
|----------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use: | Potable general<br>purpose diagnostic X-<br>ray unit | SAME | SAME |
| Size | 8.7 H x 10.4" W x<br>16.5" D | Imaging Area 14 x 17 | SAME (Combined<br>device) (A stand has<br>been added) |
| Weight | 33 lb | 10.6 lb | 207 lb. |
| Energy Source: | 90 to 285 VAC (50-60<br>Hz) | 100V, 120V,<br>230/240V(50/60Hz) | SAME (Combined<br>device) |
| User Interface | Up-Down<br>pushbuttons for kVp<br>and mAs. kVp<br>adjustable in 1 kVp<br>steps | Software Driven<br>Touch Panel LCD | SAME (Combined<br>device) |
| Exposure times | 0.001-10 sec 41 steps | N/A | SAME (Combined<br>device) |
| Ma. | 5, 6.4, 8, 10, 12.5, 16,<br>20, 25, 32, 40, 50, 64,<br>80, 100 | N/A | SAME (Combined<br>device) |
| KvP | 40 to 115 in 1 kVp<br>steps | N/A | SAME (Combined<br>device) |
| 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 Touch<br>Panel | Software Driven<br>Touch Panel LCD | SAME as CANON.<br>Or original Dedicated<br>Touch Panel |
| Performance Standard | 21 CFR 1020.30 | SAME | SAME |
| Electrical safety: | UL 2601, IEC 60601-<br>1 | SAME | SAME |

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

#### 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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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of two parts: 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 written in a 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, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

AUG 2 3 2013

Re: K042361

Trade/Device Name: Sedecal SPS-HF-4.0-D Portable X-Ray Units with Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and IZL Dated: August 30. 2004 Received: September 2, 2004

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of September 29, 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 aboye) 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

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: Sedecal SPS-HF-4.0-D Portable X-Ray Units with Detector

Indications For Use:

Indications for Use: Sedecal Portable X-Ray Units with Detector are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

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 B. Bergman

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

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