ACU-RAY HF SERIES PORTABLE X-RAY UNIT

K972204 · Sterne Equipment Co., Ltd. · IZL · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K972204
• Device Name: ACU-RAY HF SERIES PORTABLE X-RAY UNIT
• Applicant: Sterne Equipment Co., Ltd.
• Product Code: IZL · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Indications for Use

GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES

Device Story

The Sterne ACU-Ray HF is a portable X-ray unit designed for general radiographic medical imaging. It functions as a high-frequency (HF) X-ray generator to produce ionizing radiation for diagnostic purposes. The device is intended for use in clinical settings by trained healthcare professionals, such as radiologists or radiologic technologists. By capturing X-ray images, the device assists clinicians in visualizing internal anatomical structures to support diagnostic decision-making. The portable form factor allows for imaging in various clinical environments, potentially improving patient access to diagnostic services.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable high-frequency (HF) X-ray unit. Operates as a diagnostic radiological device (21 CFR 892.1720).

Indications for Use

Indicated for general radiographic medical X-ray procedures in patients requiring diagnostic 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 1997

Brent Nelson Sterne Equipment Co., LTD. 7 Research Rd. Brampton, Ontario L6W 1P4 Canada

Re:

K972204 ACU-Ray HF Series Portable X-Ray Unit Dated: June 23, 1997 Received: September 17, 1997 Regulatory class: II 21 CFR 892.1720/Procode: 90 IZL

Dear Mr. Nelson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.T.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________ 이

510 (k) Number (if known): N/A

Device Name: STERNE ACU-RAY HF

Indications for Use: GENERAL RADIOGRAPHIC MEDICAL X-RAY PROCEDURES

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over The Counter Use_________

(Optional Format 1-2-96)

David A. Heyman

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