IBA PROTON THERAPY SYSTEM- PROTEUS 235— 510(k) K082416
Substantially EquivalentIon Beam Applications S.A.
FDA 510(k) clearance K082416 for IBA PROTON THERAPY SYSTEM- PROTEUS 235, Substantially Equivalent on 2008-12-12. 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
- Traditional
- Location
- Philadelphia, PA, US
Recent devices under product code LHN
view allMore clearances from Ion Beam Applications S.A.
view allRecalls naming K082416
K-number listed on FDA's recall record- Z-0931-2018 — Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
- Z-0020-2015 — Proteus 235 Proton Therapy System for cancer treatment.
- Z-1492-2014 — Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082416.
Data sourced from openFDA. This site is unofficial and independent of the FDA.