Camera, Focal Spot, Radiographic
A radiographic focal spot camera is a test device used to measure and evaluate the size and shape of the X-ray tube focal spot, which directly affects the spatial resolution of diagnostic radiographic imaging systems in quality assurance testing. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXH, regulated under 21 CFR 892.1940, within the Radiology medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IXH
- Device Class
- FDA class 1
- Regulation Number
- 892.1940
- 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 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.