Holder, Head, Radiographic
A radiographic head holder is a positioning and immobilization accessory used to stabilize the patient's head during radiographic examinations, ensuring reproducible positioning and reducing motion artifacts in skull and facial imaging. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWY, regulated under 21 CFR 892.1920, within the Radiology medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IWY
- Device Class
- FDA class 1
- Regulation Number
- 892.1920
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925705 | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | Dec 28, 1992 | Substantially Equivalent | Denar Corp. |
| K884493 | HEAD HOLDING DEVICE/SLEEP APNEA | Jan 12, 1989 | Substantially Equivalent | X-Ray Systems |
| K884847 | MTD HEDREST | Jan 09, 1989 | Substantially Equivalent | Composites Horizons, Inc. |
| K864527 | DUOCEPH | Jan 07, 1987 | Substantially Equivalent | Gary E. Hall, Dds |
| K850197 | KELLER CEPHALOMETRIC DEVICE | Mar 22, 1985 | Substantially Equivalent | Gary D. Keller |
| K844549 | HEAD-SPINE STABILIZER HSS-1 | Mar 01, 1985 | Substantially Equivalent | Imaging Accessories, Inc. |
| K843340 | PORTA-STAT | Nov 27, 1984 | Substantially Equivalent | Porta-Stat, Inc. |
| K834559 | DELUXE WALL-MOUNTED CEPHALOMETER | Feb 21, 1984 | Substantially Equivalent | Knochen Dental Laboratory |
| K802140 | LEKSELL STEREOTACTIC SYSTEM | Feb 05, 1981 | Substantially Equivalent | Downs Surgical , Ltd. |
| K772313 | X-RAY CO-ORDINATOR | Jan 30, 1978 | Substantially Equivalent | Rinn Corp. |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.