Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Dia Imaging Analysis, Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
219 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243862 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025-03-17 | 91 | 0 |
| K243331 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2025-03-06 | 133 | 0 |
| K243235 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025-03-03 | 144 | 0 |
| K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2024-10-04 | 219 | 0 |
| K240769 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2024-05-24 | 64 | 0 |
| K222970 | LVivo IQS | Dia Imaging Analysis, Ltd. | 2023-02-01 | 127 | 0 |
| K212466 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2021-12-09 | 125 | 0 |
| K210053 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2021-02-05 | 28 | 0 |
| K202546 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2020-09-29 | 27 | 0 |
| K200232 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2020-06-23 | 145 | 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