Source, Calibration, Sealed, Nuclear
A sealed nuclear calibration source is a device containing a known quantity of radioactive material used to calibrate and verify the performance of nuclear medicine detection and imaging equipment, ensuring accurate measurement of radioactivity. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXD, regulated under 21 CFR 892.1400, within the Radiology medical specialty.
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Basic Information
- Product Code
- IXD
- Device Class
- FDA class 1
- Regulation Number
- 892.1400
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.