Collimator, X-Ray
The X-Ray Collimator is a device that attaches to an X-ray tube to restrict the size and shape of the X-ray beam, limiting patient radiation exposure to only the area of clinical interest during dental or radiographic imaging. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHB, regulated under 21 CFR 872.1840 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EHB
- Device Class
- FDA class 1
- Regulation Number
- 872.1840
- Medical Specialty
- Dental
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K921355 | WINGMASTER | Sep 25, 1992 | Substantially Equivalent | Innovators, Inc. |
| K903012 | AUDIOPRAT ENDOSCOPE | Oct 09, 1990 | Substantially Equivalent | S.C.D.P.I. of Florida, Inc. |
| K834606 | X-RAY COLLIMATOR X-CJD | Feb 21, 1984 | Substantially Equivalent | Knochen Dental Laboratory |
| K833558 | X-RAY SHIELD | Jan 13, 1984 | Substantially Equivalent | Moyco Industries, Inc. |
| K781675 | X-RAY COLLIMATOR | Dec 04, 1978 | Substantially Equivalent | General X-Ray, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.