Product Classification

• Device: security x-ray system, open beam, small
• Definition: An open x-ray system which is used for non-intrusive inspection of containers suspected to contain bombs or other weapons or contraband.
• Product Code: RBV
• 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