EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)

K012663 · Sedecal USA, Inc. · IZL · Aug 31, 2001 · Radiology

Device Facts

• Record ID: K012663
• Device Name: EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
• Applicant: Sedecal USA, Inc.
• Product Code: IZL · Radiology
• Decision Date: Aug 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The "Easy Moving™" Mobile X-ray Unit (Model SM-HF) is 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 unit (Model SM-HF) designed for diagnostic imaging; operates via 120V AC or battery power. System comprises base unit with high-voltage generator/controls and turnable arm with rotatable tube head. Operated by qualified doctors or technicians in clinical settings. Facilitates radiographic exposures of skull, spine, chest, abdomen, and extremities. Compact design allows for quick setup and positioning of patients in standing, sitting, or recumbent positions. Output is diagnostic radiographic image; used by healthcare providers to inform clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing and user testing only; no clinical data provided. Testing confirmed safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Mobile X-ray system; high-voltage generator; turnable arm with rotatable tube head. Power: 120V AC or battery. Compliance: 21 CFR 1020.30, UL-2601 (IEC 60601), UL187, and EMC IEC 60601-1-2.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Can be used with patients in sitting, standing, prone, or supine 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

• IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT (K010304)

Submission Summary (Full Text)

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K012663

## EXHIBIT 2

SEDECAL SA Pelava 9- Poligono Industrial Rio De Janeiro 28110 -Algete Madrid Spain Tel [phone] Fax [phone] (Foreign Manufacturer)

SEDECAL USA, Inc. 2910 N. Arlington Heights Rd. Arlington Heights Illinois 60006 Tel [phone] Fax [phone] (Initial Importer)

August 8, 2001

## Contact: Gary Fromberg, Official Correspondent 510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: "Easy Moving™" Mobile X-ray Unit (Model SM-HF) Classification Name: X-Ray, Mobile, Product Code 90 IZL Common/Usual Name: Stationary X-Ray System

- Equivalent legally marketed devices This product is similar in function to the 2. IROM IMAGING, INC MXR-2000 MOBILE X-RAY UNIT K010304
- Indications for Use (intended use) The "Easy Moving™™ Mobile X-ray Unit 3. (Model SM-HF) is 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: The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF)" is a mobile unit which operates from 120 V 50-60~ AC or batteries. It is easy to operate and permits a swift radiographic procedure, a feature which applies to all conventional exposure techniques on all parts of the body. The system is composed of a base unit housing the high voltage generator and controls and a turnable arm with rotatable tube head. It allows one to take exposures of patients in standing, sitting or laying position. Owing to its compact design "Easy Moving™™ Mobile X-ray Unit is a low-cost radiography system which takes up little space and is quick to set up and operate.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

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| Characteristic | IROM IMAGING, INC | "Easy Moving TM, |
|-------------------|--------------------------------|------------------|
| | MXR-2000 MOBILE | Mobile X-Ray |
| | X-RAY UNIT | System |
| | K010304 | |
| Intended Use: | Intended for use by a | SAME |
| | 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. | |
| Performance | 21 CFR 1020.30 | SAME |
| Standard | | |
| Electrical safety | Electrical Safety per | SAME, plus EMC: |
| | Underwriters Laboratories | IEC 60601-1-2 |
| | Standard UL-2601(IEC- | |
| | 60601) and IEC 60601, | |
| | Underwriters Laboratories | |
| | Standard UL187: UL | |
| | Standard for Safety for X- | |
| | Ray Equipment, | |

## 6. Substantial Equivalence Chart, "Easy Moving™M» Mobile X-Ray System

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Sedecal USA that the "Easy Moving"M" Mobile X-ray Unit is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, representing the department's focus on people and their well-being. The figures are depicted in a flowing, abstract manner, suggesting movement and progress.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEDECAL USA, Inc. % Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K012663

AUG 31 2001

Easy Moving™ Mobil X-ray Unit (Model SM-HF) (Mobil X-ray System) Dated: August 9, 2001 Received: August 13, 2001 Regulatory Class: II 21 CFR 892.1720/Procode: 90 IZL

Dear Mr. Kamm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have are in in internets we have revelved your Section 10(k) noticallor of mine and to legally marketed predicate devices marketed in interstate substantally equivalint (ifo the much to the Medical Device Amendments, or to devices that have been chat the device which a favisa which a favisa which a favisa which a favi commerce proble to May 28, 1970, the Chatinen and Cosmetic Act (Act). You may, thecesses market the device, subject to accordatics with the provisions of the Poc, Drag, and Cosmosions of the Act include requirements for annual registration, the genefal controls provisions of the Are. "The general some of thisbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such If your device is cassilied (see above) microsal States (epostal Senately found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent directing your compliance with the Current Good Manufacturing Procice requirements, 800 to 83. A substantiany equivalion (esommation assumination (21 CFR Part 820) and that, through periodic as set official in the Quality System Regulation (QS) to Medical Derrols. Failure to comply with the CMP regulation may QS Inspections, the Food allo Drug Aummistian (1 Dr.) verry sear essenting your device in the Federal Register. Please of Alternato result in Egulatory actubli. In addition submission does not affect any obligation you might have under sections 531 through note. this response to your promation sation. Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of thus of I fills tetler will and w you to begally marked 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:

> [phone] 8xx.1xxx [phone] 876.2xxx, 3xxx, 4xxx, 5xxx [phone] 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx [phone] 892.2xxx, 3xxx, 4,xxx, 5xxx (301) - 594-4692 Other

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general Also, pease note the regulation childer, "Hisolanding by reserved to promotive of Small Manufacturers, International and mornation on your responsible [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

Indications for Use (intended use) The "Easy Moving"M" Mobile X-ray Unit (Model SM-HF) is 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| | Nancy C Brogdon |
|---------------------------------------------------------------|-----------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | 4/1266.3 |

| Over-The-Counter Use | |
|----------------------|--------------------------|
| | (Optional Format 1-2-96) |

510(k) Number ..