510(k) K121448 ยท MUJ System, Planning, Radiation Therapy Treatment
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY
| Applicant | Elekta Inc. D/B/A Nucletron Corporation, Baltimore MD, US |
| Decision | Substantially Equivalent, Jul 2, 2012 |
| Received | May 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2016 | Elekta, Inc. Oncentra External Beam Oncentra Brachy
Product Usage:
Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating Terminated |
MUJ | None listed |
| Dec 18, 2015 | Elekta, Inc. Oncentra External Beam - VMAT - Radiation therapy planning system
Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in t Terminated |
MUJ | None listed |
| Jun 4, 2015 | Elekta, Inc. Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.