Curtain, Protective, Radiographic
A radiographic protective curtain is a lead-lined or radiation-attenuating flexible curtain used to shield personnel and patients from scatter radiation in radiological procedure rooms and fluoroscopy suites. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWQ, regulated under 21 CFR 892.6500, within the Radiology medical specialty.
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Basic Information
- Product Code
- IWQ
- 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 |
|---|---|---|---|---|
| K945238 | MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 | Dec 15, 1994 | Substantially Equivalent | F. Walter Hanel GmbH |
| K923099 | X-RAY DRAPES | Oct 15, 1992 | Substantially Equivalent | Hydro-Med Products, Inc. |
| K873038 | TECHTON PROTECTIVE PAD | Apr 03, 1989 | Substantially Equivalent | Techton, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.