Screen, Intensifying, Radiographic

Device Code: 5271

Product Code(s): EAM

Device Classification Information

• Device Type ID: 5271
• Device Name: Screen, Intensifying, Radiographic
• Regulation Description: Radiographic Intensifying Screen.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.1960 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EAM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-137 ISO 4090 Third Eidition 2001-08-15
  Photography - Medical Radiographic Cassette/screens/films And Hard-copy Imaging Films - Dimensions And Specifications

Total Product Life Cycle

• Device Type ID: 5271
• Device: Screen, Intensifying, Radiographic
• Product Code: EAM
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Radiographic Intensifying Screen.
• CFR Regulation Number: 892.1960 [🔎]

TPLC Last Update: 2019-04-02 21:03:25