(101 days)
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Not Found
No
The summary describes a manual x-ray collimator, a mechanical device for beam limitation, with no mention of AI/ML terms, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a "diagnostic x-ray beam-limiting device" and its intended use is to "restrict the dimension of a diagnostic x-ray field," indicating its function is for diagnosis, not therapy.
No
Explanation: The device is described as a beam-limiting device (collimator) for diagnostic x-rays, which restricts the x-ray field dimensions. It does not perform any diagnostic function such as identifying disease or providing information about the patient's health status; it only modifies the x-ray beam for imaging purposes.
No
The device description explicitly states it is a "Collimator (manual drive) – a beam limiting device," which is a physical hardware component used in diagnostic x-ray systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field." It physically shapes the x-ray beam.
- Modality: The input modality is "Diagnostic x-ray," which is an imaging technique, not a test performed on a biological sample.
This device is a component of an x-ray system used for medical imaging, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.
Product codes
KPW
Device Description
Collimator (manual drive) – a beam limiting device
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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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
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three wavy lines emanating from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Kwang C. Jung President UMI International P.O. Box 170 NORWOOD NJ 07648
DEC 2 8 2006
Re: K062788
Trade/Device Name: Collimator (manual drive) – a beam limiting device Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: KPW Dated: December 4, 2006 Received: December 6, 2006
Dear Mr. Jung:
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.
Image /page/0/Picture/10 description: The image is a black and white circular emblem. The emblem contains the letters "PA" in a stylized font in the center. Above the letters "PA" are the Roman numerals "XIX-XX". Below the letters "PA" is the word "Centennial" in a cursive font. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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Page 2 -
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
್ರಿ UMI International
P. O. Box 170 Norwood, NJ 07648, U.S.A. Tel (201)784-2950 Fax (201)784-1190
Statement of Indications for Use
510(k) Number( if known ) Device Name : Collimator( manu - a beam limiting device Indications for Use :
A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.
Prescription use
( Part 21. CFR 801 Subpart D )
and/or
Over the-Counter Use ( 21 CFR 801 Subpart C )
( Please don not write below this line - Continue on another page if needed )
Concurrence of CDRH, Office of Device Evaluation( ODE )
Nancy C. Boydon
(Division Sign-Off)
Division of Reprod and Radiological Device 510(k) Numb
( Posted Nov. 13, 2003 )
12-5-1