MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
Device Facts
| Record ID | K002833 |
|---|---|
| Device Name | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER |
| Applicant | Standard Imaging, Inc. |
| Product Code | KPT · Radiology |
| Decision Date | Sep 28, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
