Product Classification

• Device: cabinet x-ray, vehicle and cargo
• Definition: A large cabinet x-ray system used to examine pallets full of cargo to find weapons or other contraband, or a very large structure that encompasses entire vehicles being examined.
• Product Code: RCH
• 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