PROTEUS 235 PROTON THERAPY SYSTEM— 510(k) K091629

Clearance details

Applicant

Ion Beam Applications S.A.

Product code

Code LHN

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2009-06-03

Decision date

2009-08-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Louvain-La-Neuve, Be-Nota, BE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091629.