THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900
Device Facts
| Record ID | K913055 |
|---|---|
| Device Name | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 |
| Applicant | Atomic Products Corp. |
| Product Code | IZD · Radiology |
| Decision Date | Sep 6, 1991 |
| 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.