Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spectrum Dynamics Medical, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
137 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 31 | Spectrum Dynamics Medical, Ltd. | 2026-01-13 | 29 | 0 |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | 2025-12-30 | 47 | 0 |
| K230600 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 31 | Spectrum Dynamics Medical, Ltd. | 2023-04-28 | 56 | 0 |
| K212230 | TruSPECT Radiological Image Processing Station | Spectrum Dynamics Medical, Ltd. | 2021-08-16 | 31 | 0 |
| K190457 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2019-07-12 | 137 | 0 |
| K182484 | VERITON CT whole body SPECT/CT system | Spectrum Dynamics Medical, Ltd. | 2018-11-09 | 59 | 0 |
| K180514 | VERITON NM | Spectrum Dynamics Medical, Ltd. | 2018-04-25 | 57 | 0 |
| K161740 | D-SPECT Scanner, D-SPECT L Scanner | Spectrum Dynamics Medical, Ltd. | 2016-11-04 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda