Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novarad Corporation — 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) |
|---|---|---|---|---|---|
| K220146 | VisAR | Novarad Corporation | 2022-05-27 | 128 | 0 |
| K172418 | OpenSight | Novarad Corporation | 2018-09-21 | 407 | 0 |
| K171754 | NovaPACS | Novarad Corporation | 2017-07-28 | 45 | 1 |
| K160371 | NovaPACS | Novarad Corporation | 2016-10-14 | 247 | 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