INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS— 510(k) K090584
Substantially EquivalentCarl Zeiss Surgical GmbH
FDA 510(k) clearance K090584 for INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS, Substantially Equivalent on 2009-11-24. Applicant: Carl Zeiss Surgical GmbH. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Surgical GmbH
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Attleboro, MA, US
Recent devices under product code JAD
view allMore clearances from Carl Zeiss Surgical GmbH
view allRecalls naming K090584
K-number listed on FDA's recall record- Z-0001-2018 — 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
- Z-0404-2013 — INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
- Z-0405-2013 — INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Z-0406-2013 — INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.