EAK
7 FDA 510(k) clearances · Product code
41 daysmedian time to decision
241 days90th percentile
7clearances measured
FDA profile
- Official device name
- Screen, Leaded, Operator Radiation Protector
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 892.6500
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1994: 3 · 1996: 2 · 2003: 1 · 2004: 1 · 2006: 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 |
|---|---|---|
| CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (K952233) | Victoreen, Inc. | 1995-06-16 |
| ED CORP RADIATION SCREEN (K944445) | Med Corp. | 1995-05-11 |
| MULTIPLE ED1600 SERIES RADIATION SHIELDS (K944772) | Image Diagnostics, Inc. | 1994-10-20 |
| MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (K896949) | Innovative Products Mfg. | 1990-02-16 |
| CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD (K861019) | Phase One Disign Co. | 1986-04-02 |
| MODULAR X-RAY BARRIERS (K850814) | Victoreen, Inc. | 1985-04-10 |
| LEAD PLASTIC VIEWING PANELS (K850816) | Victoreen, Inc. | 1985-04-10 |
Track EAK automatically
Every clearance here is in the API, with alerts when new ones post.