Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kontron Medical Systems Sas · Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061437SIGMA 5000 SERIES, IMAGICKontron Medical Systems Sas2006-06-14210
K053084SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEMKontron Medical Systems Sas2005-11-16140
K050099SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEMKontron Medical Systems Sas2005-01-28100
K002239SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEMKontron Medical Systems Sas2000-08-08150

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