IWY · Holder, Head, Radiographic
Radiology · 21 CFR 892.1920 · Class 1
Overview
| Product Code | IWY |
|---|---|
| Device Name | Holder, Head, Radiographic |
| Regulation | 21 CFR 892.1920 |
| Device Class | Class 1 |
| Review Panel | Radiology |
| GMP Exempt | Yes |
Identification
A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925705 | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | Denar Corp. | Dec 28, 1992 | SESE |
| K884493 | HEAD HOLDING DEVICE/SLEEP APNEA | X-Ray Systems | Jan 12, 1989 | SESE |
| K884847 | MTD HEDREST | Composites Horizons, Inc. | Jan 9, 1989 | SESE |
| K864527 | DUOCEPH | Gary E. Hall, Dds | Jan 7, 1987 | SESE |
| K850197 | KELLER CEPHALOMETRIC DEVICE | Gary D. Keller | Mar 22, 1985 | SESE |
| K844549 | HEAD-SPINE STABILIZER HSS-1 | Imaging Accessories, Inc. | Mar 1, 1985 | SESE |
| K843340 | PORTA-STAT | Porta-Stat, Inc. | Nov 27, 1984 | SESE |
| K834559 | DELUXE WALL-MOUNTED CEPHALOMETER | Knochen Dental Laboratory | Feb 21, 1984 | SESE |
| K802140 | LEKSELL STEREOTACTIC SYSTEM | Downs Surgical , Ltd. | Feb 5, 1981 | SESE |
| K772313 | X-RAY CO-ORDINATOR | Rinn Corp. | Jan 30, 1978 | SESE |
Top Applicants
- Composites Horizons, Inc. — 1 clearance
- Denar Corp. — 1 clearance
- Downs Surgical , Ltd. — 1 clearance
- Gary D. Keller — 1 clearance
- Gary E. Hall, Dds — 1 clearance
