Product Code: PAS

Rf/Microwave Hyperthermia System, Cancer Treatment

Unknown

The RF/Microwave Hyperthermia System for Cancer Treatment is a therapeutic device used in conjunction with radiation therapy for the treatment of cervical carcinoma in patients who would normally receive combined chemotherapy and radiation but are ineligible for chemotherapy due to patient-related factors. It delivers radiofrequency or microwave energy to generate heat in tumor tissue, augmenting the effects of radiation. The device carries a device class of "f," indicating it follows a special or biological regulatory pathway, with no regulation number or standard medical specialty assigned; it was reviewed by the Obstetrics/Gynecology panel. It is not an implant and is not life-sustaining.

510(k)s
0
FEI Numbers
1
Registration Numbers
1
Unique Applicants
0
Years Active

Basic Information

Product Code
PAS
Medical Specialty
Unknown
Review Panel
OB
Submission Type
6

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.