DeviceClearance

Product code PDK— Radiology

ULTRABLOX

Classification name
Cream For X-Ray Attenuation
Device class
Class 2
Regulation
21 CFR 892.6510
Advisory panel
Radiology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PDK under 21 CFR 892.6510, via openFDA

Market context for product code PDK

FDA has cleared 2 devices under product code PDK between 2013 and 2014, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PDK

Recent clearances under product code PDK

Data sourced from openFDA. This site is unofficial and independent of the FDA.