510(k) K172848 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
MEVION S250i Proton Beam Radiation Therapy Device
| Applicant | Mevion Medical Systems, Littleton MA, US |
| Decision | Substantially Equivalent, Dec 27, 2017 |
| Received | Sep 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172848
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2022 | Mevion Medical Systems, Inc. Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) Open, Classified |
LHN | None listed |
| Oct 19, 2020 | Mevion Medical Systems, Inc. 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 tr Terminated |
LHN | None listed |
| May 15, 2020 | Mevion Medical Systems, Inc. MEVION S250i, MEVION S250; Proton Radiation Treatment System Terminated |
LHN | None listed |
| Oct 1, 2018 | Mevion Medical Systems, Inc. MEVION S250i Terminated |
LHN | None listed |
| Jun 29, 2018 | Mevion Medical Systems, Inc. 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 susceptib Terminated |
LHN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.