P2020-8-0 Beam Limiting Device

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K914184 ↗

FDA Product Code

KPW

Device Class

Class II

Regulation

21 CFR Part 892.1610

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K903458 Active Cleared 19 Oct 1990

• PI808 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K820178 Active Cleared 4 Mar 1982

• Precision Optics Corporation Laparoscope

  Class II

  FDA 510(k) K911744 Active Cleared 26 Jul 1991

• PHF20 20 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K935580 Active Cleared 16 Mar 1994

• P1806 Mobile C-Arm Image Intensifier

  Class II

  FDA 510(k) K792225 Active Cleared 20 Dec 1979

• Dentix Dental X-Ray Unit

  Class II

  FDA 510(k) K792307 Active Cleared 9 Jan 1980

See all devices from Precise Optics →

• What is the P2020-8-0 Beam Limiting Device used for?

  The P2020-8-0 Beam Limiting Device is designed to restrict the size and shape of the X-ray field during radiologic imaging procedures. This helps ensure precise radiation exposure, improving safety and accuracy for patients undergoing diagnostic X-ray examinations in radiology settings.

• Is the P2020-8-0 Beam Limiting Device reusable or single-use?

  The P2020-8-0 Beam Limiting Device is supplied as a reusable component. It is intended for integration into X-ray imaging systems, where it can be repeatedly used across multiple procedures, provided it is properly cleaned and maintained.

• What regulatory approval does the P2020-8-0 Beam Limiting Device hold?

  The device holds an FDA 510(k) clearance (K914184) under 21 CFR 892.1610, with a decision date of November 27, 1991. It is classified as a Class II medical device and is intended for use in radiology settings to enhance safety during diagnostic X-ray procedures.

• How is the P2020-8-0 Beam Limiting Device integrated into X-ray systems?

  The device is specifically designed for integration into X-ray imaging systems to restrict the X-ray field. It is a reusable component that attaches to the system, allowing radiologists to control the exposure area and shape during imaging, thereby optimizing diagnostic quality and minimizing unnecessary radiation.

• What are the key specifications or features of the P2020-8-0 Beam Limiting Device?

  The device is categorized under product code KPW and is intended for diagnostic X-ray use. It complies with FDA regulations to ensure precise radiation exposure control, making it suitable for use in radiology departments where accurate and safe imaging is critical.