(50 days)
This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
This device is intended to be used in the radiology.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a Beam Limiting Device R-20J. It does not contain information about acceptance criteria or a study proving that the device meets such criteria because it pertains to a traditional medical device (a collimator), not an AI/ML-driven device.
Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "device performance," "sample size," "ground truth," "MRMC study," or "standalone performance" as they relate to AI/ML device testing are not applicable to this document.
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Image /page/0/Picture/1 description: The image contains a logo with a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. To the left of the emblem, there's text arranged vertically, curving along the edge of the logo. The text and the emblem are both rendered in black, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Re: K042840
Trade/Device Name: Beam Limiting Device R-20J Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II
Product Code: 90 IZX Dated: October 4, 2004 Received: October 25, 2004
Dear Mr. Walkeri:
Shimadzu Corporation
% Mr. Randal Walkeri
Director, National Service
Shimadzu Medical Systems
20101 South Vermont Avenue
TORRANCE CA 90502-1328
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.
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 Ictter 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.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 | |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 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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Page 19
INDICATION FOR USE SECTION XIII:
Page1 of1
Unknown 510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________
Device Name: R-20J
Indications For Use :
- / This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
- / This device is intended to be used in the radiology.
- This device is operated and used by Physicians and X-ray technologist. /
- / The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use V (Per21CFR801.109)
OR
Over-The-Counter Use
Nancy C Brogdon
(Division Sign-Off) 0 0
Division of Reproductive, Abdominal,
and Radiological Devices
51((k) Number K042840
§ 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.