SDMO APPLICATOR CODE: ASN.8236
Device Facts
| Record ID | K921961 |
|---|---|
| Device Name | SDMO APPLICATOR CODE: ASN.8236 |
| Applicant | Medi-Physics Inc. Dba Nycomed Amersham Imaging |
| Product Code | IWJ · Radiology |
| Decision Date | Jul 1, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5650 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
