510(k) K121653 ยท JAD System, Therapeutic, X-Ray
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
| Applicant | Carl Zeiss Meditec, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Dec 27, 2012 |
| Received | Jun 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Carl Zeiss Meditec AG Zeiss Intrabeam Spherical Applicator 1.5 cm
REF:304534-6000-557 Open, Classified |
JAD | None listed |
| 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.