SR-130

K030494 · Source-Ray, Inc. · IZL · May 20, 2003 · Radiology

Device Facts

• Record ID: K030494
• Device Name: SR-130
• Applicant: Source-Ray, Inc.
• Product Code: IZL · Radiology
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

The Model SR-130 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

Device Story

SR-130 is a portable X-ray system designed for general radiographic imaging. Device operates by generating X-ray radiation to capture diagnostic images of patients. Used in clinical settings, such as hospitals or clinics, by trained radiologic technologists or physicians. System provides radiographic output for clinical review to assist in diagnostic decision-making. Portable design allows for bedside imaging or use in areas where stationary equipment is inaccessible, facilitating patient care by reducing need for patient transport.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mobile X-ray system; portable form factor; operates under 21 CFR 892.1720; Class II device; product code IZL.

Indications for Use

Indicated for general purpose portable radiographic applications in patients requiring diagnostic X-ray imaging.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

Mr. Ray Manez Director, Operations Source-Ray, Inc. 167 Keyland Court BOHEMIA NY 11716 Re: K030494

Trade/Device Name: SR-130, Portable X-Ray System Regulation Number: 12 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 IZL Dated: February 18, 2003 Received: February 19, 2003

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 (PMA), it may be subject to 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/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

Enclosure

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Vcr/ 3 - 4/24/96

Applicant: Source-Ray, Inc.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: X-Ray System, Portable

The Model SR-130 Portable X-Ray System is intended for General Indications For Use: Purpose Portable Radiographic Applications.

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

*Prescription Use*

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, and Radiological Device 510(k) Number

(Optional Format 1-2-96)