MEVION S250i Proton Beam Radiation Therapy Device— 510(k) K172848
Substantially EquivalentMevion Medical Systems
FDA 510(k) clearance K172848 for MEVION S250i Proton Beam Radiation Therapy Device, Substantially Equivalent on 2017-12-27. Applicant: Mevion Medical Systems. Device class: 2.
Clearance details
- Applicant
- Mevion Medical Systems
- 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
- Littleton, MA, US
Recent devices under product code LHN
view allMore clearances from Mevion Medical Systems
view allRecalls naming K172848
K-number listed on FDA's recall record- Z-0827-2022 — Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- Z-0485-2021 — MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
- Z-2406-2020 — MEVION S250i, MEVION S250; Proton Radiation Treatment System
- Z-0705-2019 — MEVION S250i
- Z-2746-2018 — MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172848.
Data sourced from openFDA. This site is unofficial and independent of the FDA.