Radiographic Intensifying Screen

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K901014 ↗

FDA Product Code

EAM

Device Class

Class I

Regulation

21 CFR Part 892.1960

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Radiation Protection Gloves

  Class I

  FDA 510(k) K900972 Active Cleared 1 May 1990

• Radiographic Grid

  Class I

  FDA 510(k) K901012 Active Cleared 28 Mar 1990

• Radiation Protection Apron

  Class I

  FDA 510(k) K896289 Active Cleared 14 Dec 1989

• Radiographic Film Cassette

  Class II

  FDA 510(k) K901013 Active Cleared 28 Mar 1990

• Radiation Protection Glasses

  Class I

  FDA 510(k) K900970 Active Cleared 1 May 1990