Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intelerad Medical Systems Incorporated — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192176 | IntelePACS | Intelerad Medical Systems Incorporated | 2020-04-02 | 234 | 2 |
| K150707 | IntelePACS | Intelerad Medical Systems Incorporated | 2015-05-27 | 69 | 0 |
| K083520 | INTELEPACS, MODEL VERSION 3.X.X | Intelerad Medical Systems Incorporated | 2009-06-23 | 209 | 1 |
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