Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bodyvision Medical , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240943 | LungVision | Bodyvision Medical , Ltd. | 2024-10-01 | 179 | 0 |
| K183593 | Lung Vision System | Bodyvision Medical , Ltd. | 2019-04-18 | 118 | 0 |
| K172955 | LungVision Tool | Bodyvision Medical , Ltd. | 2018-04-26 | 212 | 0 |
| K163622 | Lung Vision | Bodyvision Medical , Ltd. | 2017-05-11 | 140 | 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