510(k) K192065 ยท MUJ System, Planning, Radiation Therapy Treatment
Syngo.Via RT Image Suite
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Sep 18, 2019 |
| Received | Aug 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192065
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2020 | Siemens Medical Solutions USA, Inc Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK
Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180 Terminated |
MUJ | None listed |
| Jun 24, 2020 | Siemens Medical Solutions USA, Inc syngo.via RT Image Suite with software versions
syngo.via VB30 or VB40 Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.