Spectrum Dynamics Medical, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SP | January 13, 2026 |
| K253532 | TruSPECT Processing Station | December 30, 2025 |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SP | April 28, 2023 |
| K212230 | TruSPECT Radiological Image Processing Station | August 16, 2021 |
| K190457 | VERITON CT whole body SPECT/CT system | July 12, 2019 |
| K182484 | VERITON CT whole body SPECT/CT system | November 9, 2018 |
| K180514 | VERITON NM | April 25, 2018 |
| K161740 | D-SPECT Scanner, D-SPECT L Scanner | November 4, 2016 |