Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3Disc Americas — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
242 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151687 | QuantorView | 3Disc Americas | 2015-08-03 | 41 | 0 |
| K133120 | COMPUTED RADIOGRAPHY SCANNER | 3Disc Americas | 2014-01-15 | 107 | 0 |
| K133106 | COMPUTED RADIOGRAPHY SCANNER | 3Disc Americas | 2014-01-15 | 107 | 0 |
| K131442 | FIRECR DENTALIMAGING SYSTEM | 3Disc Americas | 2013-09-06 | 109 | 0 |
| K102619 | COMPUTED RADDIOGRAPHY SCANNER | 3Disc Americas | 2011-05-13 | 242 | 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