INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS— 510(k) K121653
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K121653 for INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS, Substantially Equivalent on 2012-12-27. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- 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
- Dublin, CA, US
Recent devices under product code JAD
view allMore clearances from Carl Zeiss Meditec, Inc.
view allRecalls naming K121653
K-number listed on FDA's recall record- Z-2649-2026 — Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121653.
Data sourced from openFDA. This site is unofficial and independent of the FDA.