C-TRAK BIOPSY SYSTEM
Device Facts
| Record ID | K922117 |
|---|---|
| Device Name | C-TRAK BIOPSY SYSTEM |
| Applicant | Care Wise Medical Products Corp. |
| Product Code | IZD · Radiology |
| Decision Date | Oct 14, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
