Product Classification

• Device: vehicle and cargo x-ray system, stationary
• Definition: A large system often in its own architectural structure, that does not encompass entire vehicles or cargo containers, which uses x-rays to find contraband, explosives, or weapons concealed in vehicles and cargo containers which pass through the system.
• Product Code: RCQ
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: Yes

    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

• Summary Malfunction Reporting: Ineligible

Third Party Review

Not Third Party Eligible