MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235— 510(k) K101508
Substantially EquivalentIon Beam Applications S.A.
FDA 510(k) clearance K101508 for MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235, Substantially Equivalent on 2010-08-06. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Philadelphia, PA, US
Recent devices under product code LHN
view allMore clearances from Ion Beam Applications S.A.
view allRecalls naming K101508
K-number listed on FDA's recall record- Z-2155-2021 — Proteus 235-Proton Therapy System
- Z-2424-2018 — Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
- Z-1477-2018 — Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
- Z-0938-2018 — Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
- Z-0930-2018 — Proteus 235, graphite block 8
- Z-1695-2017 — Proteus 235
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101508.
Data sourced from openFDA. This site is unofficial and independent of the FDA.