MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM

K043062 · Source-Ray, Inc. · IZL · Dec 13, 2004 · Radiology

Device Facts

• Record ID: K043062
• Device Name: MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
• Applicant: Source-Ray, Inc.
• Product Code: IZL · Radiology
• Decision Date: Dec 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Indications for Use

The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.

Device Story

Portable digital X-ray system (Model SR-130-D) designed for mobile radiographic imaging; provides diagnostic X-ray images for clinical use. Operated by trained healthcare professionals in clinical environments. Device captures X-ray radiation to produce digital images; facilitates diagnostic decision-making by clinicians. System functions as a mobile unit for point-of-care imaging.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and regulatory compliance.

Technological Characteristics

Mobile X-ray system; digital imaging capability; portable form factor; operates under 21 CFR 892.1720; subject to electronic product radiation control provisions (21 CFR 1000-1050).

Indications for Use

Indicated for portable radiographic applications in clinical settings.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2004

Mr. Ray Manez Director, Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716 Re: K043062

Trade/Device Name: Portable Digital X-Ray System Model SR-130-D Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: November 2, 2004 Received: November 8, 2004

Dear Mr. Manez:

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.

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrb/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

Enclosure

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Ver/ 3 - 4/24/96

Applicant: Source-Ray, Inc.

510(k) Number: K043062

Device Name: X-Ray System, Digital Portable

Indications For Use: The Model SR-130-D Digital Portable X-Ray System is The Model OR Too E Portable Radiographic Applications.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

*Prescription Use*

Nancy C. Brogdon

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