510(k) K090584 ยท JAD System, Therapeutic, X-Ray
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
| Applicant | Carl Zeiss Surgical GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Nov 24, 2009 |
| Received | Mar 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090584
| 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 |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
3.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments Terminated |
JAD | None listed |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
3.5 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. Terminated |
JAD | None listed |
| Nov 20, 2012 | Carl Zeiss Meditec, Inc. INTRABEAM Balloon Applicator Set;
4.0 cm,
Carl Zeiss Meditec AG, Oberkochen, Germany
INTRABEAM System is intended for radiation therapy treatments. Terminated |
JAD | None listed |
| Aug 10, 2011 | Carl Zeiss Meditec, Inc. INTRABEAM Shielding Material Flat 20 x 20 cm,
Sterile/FO
0.05 mm Pb Equivalent (50keV)
Carl Zeiss Meditec AG
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.