PDK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cream For X-Ray Attenuation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.6510
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- FDA definition
- The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ULTRABLOX (K133684) | Bloxr Corporation | 2014-01-13 |
| X-RAY ATTENUATING CREAM (DEN120022) | Bloxr Corporation | 2013-05-09 |
Track PDK automatically
Every clearance here is in the API, with alerts when new ones post.