Product Classification

• Device: cabinet x-ray explosive detection systems
• Definition: A cabinet x-ray system used for detection of explosives in closed containers such as airline baggage. Usually these systems use a non-standard x-ray mode to perform this function such as computed tomography.
• Product Code: RCF
• 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