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 P
| Device Type ID | 5421 |
| Device Name | Prostate Immobilizer Rectal Balloon |
| Physical State | Plastic Balloon |
| Technical Method | Water And Air Pressure |
| Target Area | Rectum |
| Regulation Description | Rectal Balloon For Prostate Immobilization. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.5720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PCT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5421 |
| Device | Prostate Immobilizer Rectal Balloon |
| Product Code | PCT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rectal Balloon For Prostate Immobilization. |
| CFR Regulation Number | 892.5720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDGE MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIADYNE | ||
GRANTED | 1 | |