PCT

Prostate Immobilizer Rectal Balloon

Product code

PCT

Device name

Prostate Immobilizer Rectal Balloon

Device class

Class 2

21 CFR

21 CFR 892.5720

Medical specialty

Radiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Definition text from the FDA device classification database (U.S. federal government work, public domain).