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

Atomic Energy of Canada — Predicate Candidate Screening

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

88 daysmedian FDA review time

387 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days
K850543	THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY	Atomic Energy of Canada	1985-05-10	88
K837347	LINEAR ACCELERATOR THERAC 25	Atomic Energy of Canada	1983-06-24	81
K837346	MODEL GAMMACELL 1000	Atomic Energy of Canada	1983-06-24	100
K837152	THERAC 25 LINEAR ACCELERATOR	Atomic Energy of Canada	1983-03-22	387
K771260	LINEAR ACCELERATOR G-2900	Atomic Energy of Canada	1977-08-03	21
K771096	TELHTHERAPY SIMULATOR AECL-CP, G-3200	Atomic Energy of Canada	1977-07-01	11

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