K Number
K964025
Device Name
MITAYA ALUMINUM INTERSPACED X-RAY GRID
Date Cleared
1997-06-13

(249 days)

Product Code
Regulation Number
892.1910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mitaya aluminum interspaced x_ray grid is a standard style of ... x-ray grid, used in conventional radiography techniques.
Device Description
X-Ray Grid
More Information

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Not Found

No
The summary describes a physical x-ray grid, a passive component used in conventional radiography, with no mention of software, image processing, AI, or ML.

No
The device is described as an "x-ray grid" used in "conventional radiography techniques" to assist in imaging, not for treating a disease or condition.

No
An x-ray grid is a component of an x-ray machine that helps improve image quality by reducing scatter radiation. It does not perform any diagnostic function itself. The diagnostic function is performed by a radiologist or other medical professional who interprets the x-ray images.

No

The device is described as an "aluminum interspaced x_ray grid," which is a physical hardware component used in conventional radiography. The description does not mention any software functionality.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "conventional radiography techniques," which involves taking X-ray images of the body. This is an in-vivo (within the living body) diagnostic technique, not an in-vitro (outside the living body) diagnostic technique.
  • Device Description: It's described as an "X-Ray Grid," which is a component used in X-ray machines to improve image quality. This is a medical device used for imaging, not for testing samples of bodily fluids or tissues.
  • Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.

Therefore, the Mitaya aluminum interspaced x-ray grid is a medical device used in diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes

IXJ

Device Description

Not Found

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1910 Radiographic grid.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

0

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

William Hague X-Ray Accessory Corporation 207 Day Street Danielson, CT 06239 ... JUN 1 3 1997 Re: K964025

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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:

参 We have reviewed your Section 510(k) notification of intent to market the device and we have deemnined the device is substantially equivalent for the indications for use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 equivalient 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 does not affect any obligation you might have under sections 51 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 (301) 594-4591 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William

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

1

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

彩 (

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Segmon

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over -- The-Counter Use_______________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)