MITAYA ALUMINUM INTERSPACED X-RAY GRID

K964025 · X-Ray Accessory Corp. · IXJ · Jun 13, 1997 · Radiology

Device Facts

• Record ID: K964025
• Device Name: MITAYA ALUMINUM INTERSPACED X-RAY GRID
• Applicant: X-Ray Accessory Corp.
• Product Code: IXJ · Radiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1910
• Device Class: Class 1

Intended Use

The Mitaya aluminum interspaced x-ray grid is a standard style of x-ray grid, used in conventional radiography techniques. It is used by a qualified x-ray technician, operating conventional x-ray machinery

Device Story

Mitaya aluminum interspaced x-ray grid; standard radiographic accessory. Used in conventional radiography to improve image quality by reducing scatter radiation. Operated by qualified x-ray technicians in clinical settings using conventional x-ray equipment. Device functions as a passive physical filter placed between patient and image receptor. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Aluminum interspaced x-ray grid; passive mechanical component; standard radiographic grid design.

Indications for Use

Indicated for use in conventional radiography techniques by qualified x-ray technicians operating conventional x-ray machinery.

Regulatory Classification

Identification

A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

William Hague
X-Ray Accessory Corporation
207 Day Street
Danielson, CT 06239
JUN 13 1997

Re: K964025
Mitaya Aluminum Interspaced X-Ray Grid
Dated: May 19, 1997
Received: May 22, 1997
Regulatory class: I
21 CFR 892.1910/Procode: 90 IXJ

Dear Mr. Hague:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 the Electronic 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 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 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,


Enclosure

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Page 1 of 1

510(k) Number (if known): K964025

Device Name: X-Ray Grid

Indications For Use:
The Mitaya aluminum interspaced x-ray grid is a standard style of x-ray grid, used in conventional radiography techniques.

It is used by a qualified x-ray technician, operating conventional x-ray machinery

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K964025

Prescription Use ☑
(Per 21 CFR 801.109)

OR

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