# Prostate Immobilizer Rectal Balloon
> **Product code: PCT** · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5720
## Classification
- **FDA Product Code:** PCT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 892.5720
- **Review panel:** RA
- **Medical specialty:** Radiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PCT)
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