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

Mds Nordion — Predicate Candidate Screening

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

30 daysmedian FDA review time

90 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060870	AVANZA	Mds Nordion	2006-05-15	46	0
K051065	RAYCELL X-RAY BLOOD IRRADIATOR	Mds Nordion	2005-05-26	30	0
K050963	GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN	Mds Nordion	2005-05-20	32	0
K032684	RAYCELL	Mds Nordion	2003-09-26	28	0
K010682	HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM	Mds Nordion	2001-06-05	90	0
K011246	DCM 1.0	Mds Nordion	2001-05-23	30	0
K001006	THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE	Mds Nordion	2000-04-27	29	2

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