IWY
10 FDA 510(k) clearances · Product code
63 daysmedian time to decision
154 days90th percentile
10clearances measured
FDA profile
- Official device name
- Holder, Head, Radiographic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.1920
- Medical specialty
- Radiology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1995: 1 · 1997: 2 · 2001: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (K925705) | Denar Corp. | 1992-12-28 |
| HEAD HOLDING DEVICE/SLEEP APNEA (K884493) | X-Ray Systems | 1989-01-12 |
| MTD HEDREST (K884847) | Composites Horizons, Inc. | 1989-01-09 |
| DUOCEPH (K864527) | Gary E. Hall, Dds | 1987-01-07 |
| KELLER CEPHALOMETRIC DEVICE (K850197) | Gary D. Keller | 1985-03-22 |
| HEAD-SPINE STABILIZER HSS-1 (K844549) | Imaging Accessories, Inc. | 1985-03-01 |
| PORTA-STAT (K843340) | Porta-Stat, Inc. | 1984-11-27 |
| DELUXE WALL-MOUNTED CEPHALOMETER (K834559) | Knochen Dental Laboratory | 1984-02-21 |
| LEKSELL STEREOTACTIC SYSTEM (K802140) | Downs Surgical , Ltd. | 1981-02-05 |
| X-RAY CO-ORDINATOR (K772313) | Rinn Corp. | 1978-01-30 |
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Every clearance here is in the API, with alerts when new ones post.