Definition: Used In Conjunction With Radiation Therapy For The Treatment Of Cervical Carcinoma Patients Who Normally Would Be Treated With Combined Chemotherapy And Radiation But Are Ineligible For Chemotherapy Due To Patient Related Factors.
| Device Type ID | 4128 |
| Device Name | Rf/microwave Hyperthermia System, Cancer Treatment |
| Physical State | Hyperthermia System |
| Technical Method | Hyperthermia |
| Target Area | Cervical Carcinoma |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | PAS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4128 |
| Device | Rf/microwave Hyperthermia System, Cancer Treatment |
| Product Code | PAS |