Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Atlantis Diagnostics Intl., Inc. · 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) |
|---|---|---|---|---|---|
| K980860 | HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM | Atlantis Diagnostics Intl., Inc. | 1998-04-02 | 28 | 0 |
| K961073 | ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) | Atlantis Diagnostics Intl., Inc. | 1997-02-19 | 338 | 0 |
| K936067 | ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM | Atlantis Diagnostics Intl., Inc. | 1995-10-27 | 675 | 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