Screen, Leaded, Operator Radiation Protector
The Leaded Operator Radiation Protection Screen is a shielding device positioned in a radiology or dental setting to protect the operator from scatter radiation during X-ray procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAK and the applicable regulation is 21 CFR 892.6500, under the Radiology medical specialty.
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Basic Information
- Product Code
- EAK
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | Jun 16, 1995 | Substantially Equivalent | Victoreen, Inc. |
| K944445 | ED CORP RADIATION SCREEN | May 11, 1995 | Substantially Equivalent | Med Corp. |
| K944772 | MULTIPLE ED1600 SERIES RADIATION SHIELDS | Oct 20, 1994 | Substantially Equivalent | Image Diagnostics, Inc. |
| K896949 | MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS | Feb 16, 1990 | Substantially Equivalent | Innovative Products Mfg. |
| K861019 | CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD | Apr 02, 1986 | Substantially Equivalent | Phase One Disign Co. |
| K850816 | LEAD PLASTIC VIEWING PANELS | Apr 10, 1985 | Substantially Equivalent | Victoreen, Inc. |
| K850814 | MODULAR X-RAY BARRIERS | Apr 10, 1985 | Substantially Equivalent | Victoreen, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.