IBA PROTON THERAPY SYSTEM - PROTEUS 235— 510(k) K061913

Name: FDA 510(k) clearance K061913
Creator: U.S. Food and Drug Administration
Published: 2006-07-28

Substantially Equivalent

Ion Beam Applications S.A.

FDA 510(k) clearance K061913 for IBA PROTON THERAPY SYSTEM - PROTEUS 235, Substantially Equivalent on 2006-07-28. Applicant: Ion Beam Applications S.A.. Device class: 2.

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: 2006-07-06
Decision date: 2006-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ion Beam Applications S.A.

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K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)2017-08-17
K132919 — GANTRY BEAM LINE2014-07-10
K132847 — I2C2013-11-20
K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 2352010-08-06
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Recalls naming K061913

K-number listed on FDA's recall record

Z-2434-2021 — Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiationClass II·Ongoing·Ion Beam Applications S.A.·20210614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061913.

Data sourced from openFDA. This site is unofficial and independent of the FDA.