Product code EAK— Radiology
CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
- Classification name
- Screen, Leaded, Operator Radiation Protector
- Device class
- Class 1
- Regulation
- 21 CFR 892.6500
- Advisory panel
- Radiology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code EAK
FDA has cleared devices under product code EAK between 1985 and 1995, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1995
- 1994
- 1990
- 1986
- 1985
Top applicants under product code EAK
Recent clearances under product code EAK
- K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628
- K944445 — ED CORP RADIATION SCREEN
- K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDS
- K896949 — MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
- K861019 — CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
- K850814 — MODULAR X-RAY BARRIERS
- K850816 — LEAD PLASTIC VIEWING PANELS
Data sourced from openFDA. This site is unofficial and independent of the FDA.