Product Classification

• Device: controller, temperature, radiographic
• Regulation Description: Automatic radiographic film processor.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: EGT
• Submission Type: Enforcement Discretion
• Regulation Number: 892.1900
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 4090:2001 Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.