510(k) K080601 ยท MUJ System, Planning, Radiation Therapy Treatment
ERGO++ VERSION 1.7
| Applicant | 3D Line Medical Systems S.R.L., Norcross GA, US |
| Decision | Substantially Equivalent, Jun 6, 2008 |
| Received | Mar 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080601
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2017 | Elekta Inc Elekta ERGO++
Product Usage:
ERGO is often used for stereotactic treatments. Terminated |
MUJ | None listed |
| Jun 23, 2011 | Computerized Medical Systems Inc ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1
Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.