510(k) K110590 ยท JAD System, Therapeutic, X-Ray
INTRABEAM NEEDLE APPLICATOR
| Applicant | Carl Zeiss Surgical GmbH, Dublin CA, US |
| Decision | Substantially Equivalent, Apr 13, 2012 |
| Received | Mar 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110590
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2017 | Carl Zeiss Meditec AG Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany.
The INTRABEAM System is indicated for radiation therapy treatments Terminated |
JAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.