Barrier, Control Panel, X-Ray, Movable
A movable X-ray control panel barrier is a portable or adjustable radiation-attenuating shield positioned between the X-ray control console and the examination area to protect the operator from scatter radiation during radiological procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWX, regulated under 21 CFR 892.6500, within the Radiology medical specialty.
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Basic Information
- Product Code
- IWX
- Device Class
- FDA class 1
- Regulation Number
- 892.6500
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881591 | A2J MZ 45 LASER LIGHT FOR POSITIONING | Apr 27, 1988 | Substantially Equivalent | A2j, Inc. |
| K850813 | MOBILE LEAD PLASTIC X-RAY BARRIERS | Apr 10, 1985 | Substantially Equivalent | Victoreen, Inc. |
| K781068 | AUTOMATIC FILM PROCESSORIO M. R80 | Jul 17, 1978 | Substantially Equivalent | Tecnomed, Inc. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.