Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Healthcare Integrated IT Solutions · 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) |
|---|---|---|---|---|---|
| K121387 | CENTRICITY PACS-IW | Ge Healthcare Integrated IT Solutions | 2012-06-05 | 28 | 1 |
| K112570 | CENTRICITY CARDIO IMAGING | Ge Healthcare Integrated IT Solutions | 2011-11-30 | 85 | 1 |
| K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE | Ge Healthcare Integrated IT Solutions | 2011-09-26 | 110 | 1 |
| K063628 | CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HA | Ge Healthcare Integrated IT Solutions | 2006-12-26 | 20 | 3 |
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