Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imaging Engineering, LLC — 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) |
|---|---|---|---|---|---|
| K251650 | Insight Enhancedâ„¢ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025-09-16 | 110 | 0 |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | 2021-07-27 | 161 | 0 |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | 2020-03-06 | 17 | 0 |
| K191310 | Insight Essentials DRF Digital Imaging System | Imaging Engineering, LLC | 2019-06-10 | 26 | 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