510(k) K051055 ยท JAD System, Therapeutic, X-Ray
INTRABEAM SYSTEM
| Applicant | Carl Zeiss Surgical GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, May 23, 2005 |
| Received | Apr 26, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051055
| 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 |
| 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.