Source, Calibration, Sealed, Nuclear

Device Code: 5304

Product Code(s): IXD

Device Classification Information

• Device Type ID: 5304
• Device Name: Source, Calibration, Sealed, Nuclear
• Regulation Description: Nuclear Sealed Calibration Source.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.1400 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IXD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5304
• Device: Source, Calibration, Sealed, Nuclear
• Product Code: IXD
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Nuclear Sealed Calibration Source.
• CFR Regulation Number: 892.1400 [🔎]

TPLC Last Update: 2019-04-02 21:04:00