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

Ion Beam Applications S.A. — Predicate Candidate Screening

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

102 daysmedian FDA review time

296 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163500	IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus	Ion Beam Applications S.A.	2017-08-17	247	7
K132919	GANTRY BEAM LINE	Ion Beam Applications S.A.	2014-07-10	296	0
K132847	I2C	Ion Beam Applications S.A.	2013-11-20	70	1
K101508	MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235	Ion Beam Applications S.A.	2010-08-06	66	2
K100766	IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235	Ion Beam Applications S.A.	2010-07-21	126	0
K092796	IBA PROTON THERAPY SYSTEM, PROTEUS 235	Ion Beam Applications S.A.	2009-12-22	102	0
K091629	PROTEUS 235 PROTON THERAPY SYSTEM	Ion Beam Applications S.A.	2009-08-11	69	0
K083058	IBA PROTON THERAPY SYSTEM - PROTEUS 235	Ion Beam Applications S.A.	2009-04-15	183	0
K082416	IBA PROTON THERAPY SYSTEM- PROTEUS 235	Ion Beam Applications S.A.	2008-12-12	113	2
K061913	IBA PROTON THERAPY SYSTEM - PROTEUS 235	Ion Beam Applications S.A.	2006-07-28	22	1
K060695	IBA PROTON THERAPY SYSTEM - PROTEUS 235	Ion Beam Applications S.A.	2006-04-11	26	0
K053641	IBA PROTON THERAPY SYSTEM-PROTEUS 235	Ion Beam Applications S.A.	2006-01-24	25	0
K983024	PROTON THERAPY SYSTEM	Ion Beam Applications S.A.	2001-07-12	1046	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