IWY — Holder, Head, Radiographic Class I
FDA product code IWY covers "Holder, Head, Radiographic", a Class I medical device regulated under 21 CFR 892.1920. Submissions are reviewed by the Radiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IWY
- Device Class
- Class I
- Regulation Number
- 892.1920
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K925705 | denar | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | December 28, 1992 |
| K884493 | x-ray systems | HEAD HOLDING DEVICE/SLEEP APNEA | January 12, 1989 |
| K884847 | composites horizons | MTD HEDREST | January 9, 1989 |
| K864527 | gary e. hall, dds | DUOCEPH | January 7, 1987 |
| K850197 | gary d. keller | KELLER CEPHALOMETRIC DEVICE | March 22, 1985 |
| K844549 | imaging accessories | HEAD-SPINE STABILIZER HSS-1 | March 1, 1985 |
| K843340 | porta-stat | PORTA-STAT | November 27, 1984 |
| K834559 | knochen dental laboratory | DELUXE WALL-MOUNTED CEPHALOMETER | February 21, 1984 |
| K802140 | downs surgical | LEKSELL STEREOTACTIC SYSTEM | February 5, 1981 |
| K772313 | rinn | X-RAY CO-ORDINATOR | January 30, 1978 |